Executive summary
Prepared for investor due diligence · all figures from company-supplied Tally statements and operational registers
Sycon Clinical Research is a Gandhinagar-based contract research organization running bioequivalence and bioanalytical studies for Indian and European sponsors. FY 2025-26 was a genuine inflection year: revenue more than doubled and losses collapsed to roughly an eighth of the prior year. Two caveats govern how much weight that carries — the FY26 accounts are provisional and pre-audit, and they carry no depreciation charge.
FY26 revenue
₹8.66 Cr
▲ 112% vs FY25
Gross margin
75.6%
▲ 16.4 pts
Net loss
₹0.53 Cr
from ₹4.16 Cr
Validated methods
32
of 51 in portfolio
Studies to date
72
29 currently live
Total debt
₹14.16 Cr
▲ 47% over 3 yrs
What the business has built
The durable asset here is not the P&L — it is the method portfolio and the sponsor relationships. Fifty-one validated or in-development LC-MS/MS assays represent several years of accumulated development effort that a new entrant cannot shortcut. Eight of them quantify at picogram level, which is the technical tier where CROs earn premium pricing. The client list reaches regulated Western markets: 38 of 72 studies target EMA, UK MHRA, US FDA or WHO submissions rather than DCGI alone.
What an investor must price in
- The FY26 loss is understated. No depreciation was charged in FY26 against ₹3.11 Cr of gross fixed assets, while FY24 and FY25 carried ₹1.07 Cr and ₹0.79 Cr respectively. A normalised charge puts the real FY26 loss nearer ₹1.3 Cr.
- Roughly half the live order book is method-dependent. 15 of 29 ongoing studies rely on bioanalytical methods not yet validated. Revenue recognition on those is conditional on development completing.
- Cash conversion has deteriorated sharply. Receivables rose 341% to ₹1.65 Cr while bank balances fell to ₹5.7 lakh. The revenue growth is real but largely uncollected.
- The company is funded by unsecured lending. Unsecured loans grew from ₹5.34 Cr to ₹11.21 Cr while secured debt was paid down. Terms, interest and subordination are undisclosed.
- Single-platform concentration. All 51 methods run on LC-MS/MS and 50 of 51 use plasma. There is no ligand-binding, biologics or biosimilar capability — simultaneously the key concentration risk and the clearest growth thesis.
This report is compiled solely from documents supplied by the company: Tally-generated balance sheets and profit & loss statements for FY2023-24 to FY2025-26, a validated-method register dated 01 Jun 2026, a project tracker dated 08 Jul 2026, a master study list dated 24 Jul 2026, and HR annexures for the organogram and technical staff. No audited accounts, contracts, accreditation certificates or inspection reports were provided. Nothing here has been independently verified.
Company profile
Constitution, registration and facility
| Legal name | Sycon Clinical Research Private Limited |
|---|---|
| CIN | U73100GJ2021PTC124390 |
| Incorporated | 2021 (Gujarat), private limited company |
| MSME registration | UDYAM-GJ-09-0016990 (Micro / Manufacturing) |
| Registered office | 5th Floor, Shree Sarju Arena, Opp. Kadi Nagarik Bank, Zundal, Gandhinagar, Gujarat 382421 |
| Paid-up share capital | ₹15.00 lakh |
| Reserves & surplus (FY26) | ₹10.06 Cr — requires explanation |
| Headcount | 55 positions listed in the technical staff annexure (version 08, dated 22 Jun 2026) |
A company with ₹15 lakh paid-up capital and cumulative losses across all three years reports ₹10.06 Cr under Reserves & Surplus. This is almost certainly securities premium or a capital contribution rather than accumulated earnings, but the Tally extract does not disaggregate it. The composition of this balance, the shareholding pattern and any instrument terms attaching to it are the first items to request.
The Udyam registration classifies Sycon as a micro enterprise in the manufacturing category. For a services CRO with ₹8.66 Cr turnover this classification appears inconsistent with both the activity and the current MSME turnover thresholds, and may affect eligibility for the interest subvention and payment-protection provisions the company appears to rely on.
Service lines & revenue mix
What Sycon sells, and a nomenclature change that breaks year-on-year comparability
Sycon operates an integrated BA/BE model: a clinical unit that doses and samples volunteers, and a bioanalytical laboratory that quantifies drug concentrations by LC-MS/MS. Revenue is earned per study, with pilot studies priced below pivotal ones, and some engagements sold clinical-only where the sponsor runs its own bioanalysis.
Revenue head composition across three years
Reported revenue heads as they appear in the Tally P&L, INR Cr
Read with care. The revenue heads were renamed in FY26. What was previously split across analytical, plasma and BA-BE research income is now reported as biological matrix service and clinical research service. The underlying activity may be unchanged, but the reported series is not continuous.
FY24 reported two revenue heads, FY25 reported three, and FY26 reports two entirely different ones. Without a mapping from old heads to new, three-year revenue-mix analysis at service-line level is not possible from these statements. Request the reconciliation.
Observable mix from the operational registers
The study lists give a cleaner view of activity than the revenue heads do. Of 72 studies on the master list, 43 are pivotal and 29 are pilot. Pivotal studies are larger, longer and materially better priced, so the mix shifting toward pivotal work is a positive signal — though no per-study values were supplied to confirm it in revenue terms.
Molecule & method portfolio
The core asset — 51 bioanalytical methods, their technical depth, and how much revenue-generating work they have actually carried
A validated bioanalytical method is a capitalised asset in everything but accounting treatment. Each one absorbs months of development, reference standards, instrument time and regulatory-grade validation before it earns a rupee. Once validated it can be run repeatedly at high incremental margin. This section treats the portfolio the way an acquirer should: as accumulated capability, priced by depth, breadth and utilisation.
Total methods
51
32 validated · 7 dev complete · 12 in dev
Ultra-trace assays
8
quantifying below 0.1 ng/mL
Multi-analyte methods
19
simultaneous quantification
Therapeutic areas
12
derived classification
Methods used in studies
47
92% conversion to work
Analytical platform
1
LC-MS/MS only
Technical depth: assay sensitivity
The lower limit of quantification is the most objective proxy for method difficulty available from these documents. Assays reading in picograms per millilitre demand aggressive sample clean-up, high-sensitivity instrumentation and tight matrix-effect control; assays in the tens of nanograms are comparatively routine. Sycon holds 8 methods in the ultra-trace band, five of them fully validated.
Method portfolio by lower limit of quantification
Count of methods per sensitivity band, split by development stage
The ultra-trace band is the differentiator. Progesterone and Chlorpromazine at 25 pg/mL, Rasagiline at 20 pg/mL and Fludrocortisone at 30 pg/mL sit at a technical tier most mid-size Indian CROs do not hold. Sirolimus is also the portfolio’s only whole-blood assay.
Breadth: therapeutic coverage
Classifying the 51 molecules pharmacologically shows where the portfolio concentrates. CNS and cardiometabolic together account for 23 of 51 methods — both large, crowded generic categories with steady BE demand. Coverage is thin in oncology, antivirals and biologics, which are the higher-value segments.
Therapeutic area distribution of the method portfolio
Methods per therapeutic class, split by development stage
Derived classification. The source documents contain no therapeutic categorisation; molecules were classified pharmacologically for this analysis. Where a combination spans classes it is assigned to the primary indication.
Utilisation: has the portfolio actually earned?
Method development is a sunk cost until a study runs on it. Cross-mapping the method register against the 72-study master list shows which assets have converted and which are idle capacity.
Studies conducted per validated method
Validated methods ranked by number of linked studies on the master list
2 validated methods have carried no study yet — Paclitaxel, Total ubiquinone and Dydrogesterone. That is either latent capacity awaiting a sponsor, or development effort spent against demand that did not arrive. Conversely the paracetamol and dapagliflozin families have each carried multiple studies, showing the compounding return a well-chosen method delivers.
Platform and matrix concentration
Every one of the 51 methods runs on LC-MS/MS, and 50 of 51 use human plasma — Sirolimus in whole blood is the sole exception. There is no ligand-binding assay capability, no immunoassay, no biologics or biosimilar bioanalysis, and no alternative matrices such as urine, serum or dried blood spot on the register. The entire scientific franchise rests on one technique applied to one matrix. This concentrates instrument risk, limits addressable market to small-molecule generics, and caps pricing power in exactly the segment facing the most competitive pressure. It is also the most obvious value-creation lever available to an incoming investor.
Order book dependency on unvalidated methods
The most material operational finding in this pack. Mapping the 29 ongoing studies in the project tracker against method validation status shows how much of the live book rests on science that is not yet finished.
| Study | Sponsor | Target completion | Method status |
|---|---|---|---|
| Cefuroxime Axetil 500 mg + Potasium Clavulanic Acid 125 mg Film Coated Tablet | Mankind Pharma Ltd | 2026-07 | Under development |
| PMCF Study-Flowable Gelatin Haemostatic matrix Kit | Aegis Lifescience Pvt. Ltd | Need to confirm | No method on file |
| Pyridostigmine 60 mg Tablets | Orbit Pharma Limited, UK | 2026-08 | No method on file |
| Azithromycin 250 mg Tablets | Mankind Pharma Ltd | 2026-08 | Under development |
| Edoxaban 60 mg tablets | Stallion | 2026-08 | Under development |
| Cefuroxime Axetil 250 mg Film Coated Tablet | Mankind Pharma Ltd | 2026-09 | Under development |
| Amoxycillin 250 mg + Potasium Clavulanic Acid 125 mg Film Coated Tablet | Mankind Pharma Ltd | 2026-09 | Under development |
| Dapagliflozin 5 mg + Sacubitril 97 mg & Valsartan 103 mg Tablet-Fully Replicate | Ravenbhel Pharma | 2026-09 | Under development |
| Etoricoxib 60mg and Thiocolchicoside 4 mg Tablets | Mankind Pharma Ltd | 2026-09 | Under development |
| Aceclofenac 100mg and Paracetamol 325 mg Tablet | Mankind Pharma Ltd | 2026-10 | Under development |
| Aceclofenac 100mg + Paracetamol 325 mg + Serratiopeptidase 15mg Tablet | Mankind Pharma Ltd | 2026-10 | Under development |
| Amoxycillin 200mg and Potassium Clavulanate 28.5 mg | Mankind Pharma Ltd | 2026-10 | Under development |
| Spironolactone 12.5 mg Tablet (2 X 12.5 mg), 2 way crossover | Syrimed, UK | 2026-10 | Under development |
| Ezetimibe Oral Suspension, 10 mg/5 mL | Syrimed, UK | 2026-12 | Under development |
| Tegoprazan 50mg Tablets | Insignia | 2026-12 | Under development |
| Resmetirom 100 mg Tablets | Eris Lifescience Ltd | Need to confirm | Under development |
Fifteen of the 29 ongoing studies depend on bioanalytical methods still under development, and Pyridostigmine 60 mg for Orbit Pharma has no method on the register at all. That is roughly half the live book carrying method-development execution risk ahead of the stated completion dates. The PMCF study for Aegis Lifescience is excluded from this concern — it is a post-market clinical follow-up on a haemostatic device and does not require a bioanalytical assay. Any revenue model built on the stated completion schedule should be probability-weighted for method-validation slippage, which in this industry routinely runs one to two quarters.
Client portfolio & order book
Sponsor concentration, regulatory reach and the forward schedule
Studies by sponsor
Master study list, 72 studies across 15 sponsors
Concentration is material. The top four sponsors account for 48 of 72 studies (67%). No revenue-by-client data was supplied, so value concentration — the number that actually matters — cannot be computed. This is the single most important information gap in the pack.
Regulatory pathway mix
Target submission authority across the master study list
Export-facing work dominates. Studies aimed at EMA, UK MHRA, US FDA and WHO outnumber DCGI-only work, which supports both premium pricing and the claim of regulated-market competence. Two US FDA studies were run under PEPFAR for Emcure. No inspection or accreditation evidence was supplied to corroborate the capability these submissions imply.
Study completion timeline
Studies by target completion month, project tracker dated 08 Jul 2026
29 studies are scheduled to complete between now and December 2026, with four carrying no confirmed date. The concentration of deliveries in Q3 FY27 is a capacity question: the clinical unit and the laboratory must both absorb that throughput simultaneously.
The master study list carries 72 studies; the project tracker carries 56. The two documents were issued sixteen days apart and do not reconcile. Several studies appear on one and not the other, and sponsor attribution differs in at least three cases — Spironolactone is attributed to Olive Pharmascience on the master list and Syrimed UK on the tracker. Request a single reconciled register.
Organization & management
Leadership bench, headcount structure and qualification profile
The senior team is experienced and appropriately credentialled for a CRO of this size. The Managing Director is a pathologist, the CEO and QA Head are organic chemists with a combined fifty-two years, and clinical and bioanalytical functions are separately headed — which is the right structural separation for regulatory credibility.
| Name | Role | Experience | Qualification |
|---|---|---|---|
| Dr. Umang Gandhi | Managing Director | 20+ years | M.D. (Pathology) |
| Mr. Kamlesh Panchal | CEO / Unit Head | 28 years | M.Sc. (Organic Chemistry) |
| Mr. Malav Shah | Head - Quality Assurance | 24+ years | M.Sc. (Organic Chemistry) |
| Dr. Nirav Panchal | Head - Clinical / PI | 16+ years | M.B.B.S. |
| Dr. Peeyush Jain | Head - Bio-analytical | 20+ years | M.Pharm, Ph.D |
| Mr. Nitin Makvana | Finance Head | 26+ years | M.Sc., C.M.L.T. |
| Mr. Viral Patel | Head - Project Mgmt & BD | 15 years | M.Pharm |
| Mr. Udit Topre | Manager - HR & Admin | 10+ years | MBA (HR) |
Technical staff qualification and experience profile
From the technical staff annexure, 55 positions
A barbell profile. Roughly a third of staff carry ten or more years of experience while another third are freshers or under three years. The middle is thin, which is typical of a company that has scaled headcount quickly and now depends heavily on a small senior cohort for supervision and regulatory defensibility.
Clinical, bioanalytical and quality functions each rest on a single named individual, with no deputy identified in the organogram. For a business whose regulatory standing depends on named responsible persons, the departure of any one of Dr. Nirav Panchal, Dr. Peeyush Jain or Mr. Malav Shah would be materially disruptive. Retention arrangements and succession planning should be diligenced directly.
The technical staff file is named Annexure-13 but its printed header reads ANNEXURE-04. The organogram is version 08 dated 04 Feb 2026 while the staff annexure is version 08 dated 22 Jun 2026 — the same version number on two documents four months apart. Role attribution also differs between the two: the organogram’s arrangement of Viral Patel, Dr. Peeyush Jain and Nitin Makvana does not align cleanly with the designations in the staff annexure. Both documents are stamped REFERENCE COPY rather than issued as controlled copies.
Three-year financial analysis
All figures INR Cr · FY 2025-26 is provisional and pre-audit
Revenue, gross margin and net loss
Bars show revenue and gross profit in INR Cr; line shows gross margin percentage
FY26 is a step change on every line. Revenue rose 112%, gross margin expanded 16.4 points to 75.6%, and the net loss narrowed to ₹0.53 Cr from ₹4.16 Cr. Direct costs grew only 27% against 112% revenue growth — strong operating leverage, consistent with a business filling previously idle capacity.
| Profit & loss | FY 2023-24 | FY 2024-25 | FY 2025-26 |
|---|---|---|---|
| Revenue from operations | 4.03 | 4.09 | 8.66 |
| Direct expenses | 1.43 | 1.67 | 2.11 |
| Gross profit | 2.60 | 2.42 | 6.55 |
| Gross margin | 64.5% | 59.2% | 75.6% |
| Indirect expenses | 5.48 | 6.65 | 7.08 |
| Other income | 0.11 | 0.06 | 0.01 |
| Net loss | 2.77 | 4.16 | 0.53 |
Indirect expense build-up
Indirect expense composition
Major indirect expense heads across three years, INR Cr
Employee cost is the dominant and fastest-growing line, rising from ₹1.34 Cr to ₹2.30 Cr. Bio-analytical spend grew fivefold, consistent with the method-development activity documented in the portfolio section. Note the depreciation column: ₹1.07 Cr, then ₹0.79 Cr, then nil.
| Expense head | FY 2023-24 | FY 2024-25 | FY 2025-26 | FY24→26 |
|---|---|---|---|---|
| Employee benefit (HR) | 1.34 | 1.76 | 2.30 | +72% |
| Financial & other | 0.89 | 1.06 | 1.24 | +39% |
| Administrative & office | 0.90 | 1.12 | 1.05 | +16% |
| Clinical | 0.31 | 0.44 | 0.95 | +204% |
| Professional fees | 0.74 | 1.15 | 0.91 | +23% |
| Business development | 0.11 | 0.05 | 0.29 | +163% |
| Bio-analytical | 0.04 | 0.09 | 0.22 | +405% |
| IT | 0.05 | 0.08 | 0.09 | +93% |
| Depreciation | 1.07 | 0.79 | 0.00 | -100% |
| Commission | 0.00 | 0.09 | 0.00 | n/a |
Quality of earnings
Adjustments an acquirer should make before treating FY26 as a normalised base
The FY26 profit & loss account contains no depreciation line. FY24 charged ₹1.07 Cr and FY25 charged ₹0.79 Cr. Over the same period gross fixed assets rose from ₹2.36 Cr to ₹3.11 Cr, with plant and machinery increasing ₹0.74 Cr — so the asset base grew while the charge went to nil. Applying a charge in line with FY25 lifts the FY26 loss from ₹0.53 Cr to approximately ₹1.28 Cr. Until the fixed asset register and depreciation schedule are produced, the headline turnaround should be treated as materially overstated.
FY26 figures are pre-audit. Statutory audit commonly produces adjustments for revenue cut-off, expense accruals, provisioning against receivables and deferred tax. Given the receivables build described below, an expected credit loss provision is a realistic audit outcome that would further widen the loss.
The balance sheet carries a deferred tax asset of ₹0.22 Cr, and FY24 and FY25 both recognised deferred tax income in the P&L. Recognition of a deferred tax asset requires reasonable certainty of future taxable profit. For a company with three consecutive years of losses this is a judgement an auditor may challenge; reversal would be a further charge.
Financial and other expenses of ₹1.24 Cr sit against ₹14.16 Cr of debt, of which ₹11.21 Cr is unsecured and likely related-party. If that lending is interest-free or below market, reported finance cost understates a standalone cost structure. Conversely, if it converts to equity on a transaction, the charge disappears. Either way the reported figure is not a normalised one.
Indicative normalised position
| FY 2025-26 reconciliation | INR Cr |
|---|---|
| Reported net loss | 0.53 |
| Add: depreciation at FY25 run rate | 0.75 |
| Potential: receivables provision | not estimated |
| Potential: deferred tax asset reversal | not estimated |
| Indicative adjusted loss (before unquantified items) | 1.28 |
The depreciation adjustment applies the FY25 charge as a proxy. Actual figures require the fixed asset register, which was not supplied.
Working capital & debt
Cash conversion, receivables quality and the funding structure
Debt, receivables and cash
Secured and unsecured borrowing against receivables and bank balances, INR Cr
The trend lines diverge in the wrong direction. Debt and receivables both climb while cash falls to ₹5.7 lakh. Sycon is funding a growing receivable book with incremental unsecured borrowing rather than with collections.
| Balance sheet | FY 2023-24 | FY 2024-25 | FY 2025-26 |
|---|---|---|---|
| Secured loans | 4.32 | 3.67 | 2.95 |
| Unsecured loans | 5.34 | 9.16 | 11.21 |
| Current liabilities | 0.48 | 0.84 | 1.90 |
| Fixed assets | 3.07 | 2.36 | 3.11 |
| Current assets | 1.32 | 1.41 | 2.51 |
| of which sundry debtors | 0.40 | 0.37 | 1.65 |
| of which bank balances | 0.11 | 0.41 | 0.06 |
| Balance sheet total | 10.13 | 13.68 | 16.07 |
Receivable days
Computing debtor days on closing balances: FY24 37 days, FY25 33 days, FY26 70 days. The FY26 deterioration is significant even allowing for revenue having doubled, and closing-balance methodology understates the position where revenue is back-loaded into the final quarter — which the study completion timeline suggests it was.
At FY 2025-26 year end the company held ₹5.7 lakh in bank balances and ₹3.4 lakh in cash against current liabilities of ₹1.90 Cr, including ₹0.42 Cr of salary payable and ₹0.32 Cr of professional fees payable. Salary payable at year end rose from ₹21.0 lakh to ₹42.4 lakh. Deferred payroll of this magnitude is a working capital stress indicator and should be probed directly with management.
Unsecured loans of ₹11.21 Cr are now 79% of total debt, up from 55% three years ago. The statements do not disclose lender identity, interest rate, tenor, security or subordination. If promoter-funded, the treatment of this balance on a transaction — repayment, conversion or retention — is a first-order commercial term, not a detail.
Risk register
Ranked by likely impact on valuation and deal structure
| Area | Risk | Rating | Diligence action |
|---|---|---|---|
| Financial | FY26 loss understated by absent depreciation charge | High | Obtain fixed asset register and depreciation schedule; recompute FY26 result |
| Financial | Accounts provisional and pre-audit; audit adjustments likely | High | Await signed audited financials before pricing; model a downside adjustment case |
| Operational | 15 of 29 ongoing studies depend on unvalidated methods | High | Obtain method development timelines and probability-weight the order book |
| Liquidity | Receivables up sharply, cash at ₹5.7 lakh, payroll deferred | High | Ageing analysis by client; confirm collection since year end; review payroll timing |
| Capital | ₹11.21 Cr unsecured lending with undisclosed terms | High | Related-party schedule with rates, tenor, security and subordination |
| Commercial | Top four sponsors carry 67% of studies; value concentration unknown | Medium | Revenue by client for three years; contract terms and renewal history |
| Scientific | Single platform (LC-MS/MS) and single matrix (plasma) | Medium | Assess capex and timeline to add ligand-binding and biologics capability |
| Regulatory | No accreditation, licence or inspection evidence supplied | High | CDSCO registration, NABL/GLP certificates, full inspection history and CAPA closure |
| People | Clinical, bioanalytical and QA each depend on one named individual | Medium | Retention terms, notice periods, succession plan, named deputies |
| Governance | Uncontrolled document copies; version and annexure numbering errors | Medium | Review document control SOP and QMS maturity; sample controlled-copy issuance |
| Accounting | ₹10.06 Cr reserves against ₹15 lakh paid-up capital, unexplained | Medium | Share capital history, premium schedule, cap table, any instrument terms |
| Compliance | MSME classification as micro/manufacturing inconsistent with activity and turnover | Low | Confirm Udyam basis and any benefits claimed on that footing |
Document inconsistencies
Observed while compiling this report — recorded because data-room hygiene is itself diligence evidence
Molecule naming variants
The same molecule is spelled differently across the method register, master study list and project tracker. Individually trivial; collectively they indicate the three registers are maintained independently without a controlled vocabulary, which for a GLP-facing organisation is a quality-system observation.
| Molecule | Variants observed |
|---|---|
| Paclitaxel | Paclitexal (method list) vs Paclitaxel (study list) |
| Rasagiline | Rasaglin (method list) vs Rasagiline (study list) |
| Esaxerenone | Esaxerenone (method list) vs Esaxaserone (study list, project tracker) |
| Dydrogesterone | Dydrogesterone (method list) vs Dydogesterone (study list) |
| Amoxicillin | Amoxicillin (method list) vs Amoxycillin (study list, project tracker) |
| Levosulpiride | Levosulpride (method list) vs Levosulpiride (study list) |
| Ubiquinone | Ubiquinone, Ubiquinol and CoEnzyme Q10 used interchangeably across all three files |
Structural inconsistencies
- Study register mismatch. Master study list carries 72 studies; project tracker carries 56. Issued sixteen days apart, they do not reconcile.
- Sponsor attribution conflicts. Spironolactone 12.5 mg is attributed to Olive Pharmascience on the master list and Syrimed UK on the tracker. Esaxerenone appears against Syrimed UK on one and Exemed Pharmaceuticals on the other.
- Annexure numbering. File supplied as Annexure-13 Technical Expertise; the document header reads ANNEXURE-04 Technical Staff Details.
- Version control. Organogram and staff annexure both carry Version 08 despite dates four months apart (04 Feb 2026 and 22 Jun 2026).
- Uncontrolled copies. Both HR annexures are stamped REFERENCE COPY rather than issued as controlled documents.
- Regulator typo. The project tracker records “UKNHRA” against the Quetiapine oral suspension study.
- Study type typos. “Pivoal” and “Piovtal” appear in the Pilot/Pivotal column.
- Completion date format. One tracker entry records “Mar-May-26” as a range where all others carry a single date; four entries read “Need to confirm”.
- Entity naming. Tally files are headed “SYCON CLINICAL RESEARCH PRIVATE LIMITED_(01.04.23)” for FY24 and FY25 but “_25-26” for FY26, suggesting separate company files rather than a continuous ledger.
Information request list
Items required to complete diligence, not present in the documents supplied
Financial
- Audited financial statements FY24, FY25 and FY26 with full notes and schedules
- Fixed asset register with depreciation schedule and FY26 charge computation
- Debtor ageing by client at year end and collections received since
- Related-party schedule: lender identity, rate, tenor, security, subordination
- Share capital history, securities premium schedule and current cap table
- GST returns and reconciliation to reported revenue
- Bank sanction letters, facility terms and covenant compliance
- Salary payable ageing and confirmation of payroll currency
Commercial
- Revenue by client for three years
- Order book with contract value per ongoing study
- Master service agreements and rate cards for top six sponsors
- Win/loss history and quotation pipeline
- Historical realised price per pilot and per pivotal study
Scientific & regulatory
- CDSCO registration and current licence status
- NABL, GLP and any other accreditation certificates with scope
- Complete regulatory inspection history with findings and CAPA closure
- Method development timelines for the sixteen at-risk ongoing studies
- Instrument inventory with age, AMC status and utilisation
- Clinical unit bed capacity and historical utilisation
- SOP index and QMS documentation maturity assessment
Organizational
- Reconciled single study register replacing the two supplied
- Employment contracts and notice periods for named function heads
- Attrition data by function for three years
- Succession plan and identified deputies for PI, bioanalytical and QA roles
Appendix: molecule master
All 51 bioanalytical methods with sensitivity, matrix, complexity, classification and linked commercial activity
| # | Molecule | Stage | LLOQ | Matrix | Analytes | Therapeutic area | Studies | Sponsors |
|---|---|---|---|---|---|---|---|---|
| 1 | Paclitaxel | Validated | 400 pg | Plasma | 1 | Oncology & immunology | 1 | Meril |
| 2 | Sirolimus | Validated | 50 pg | Blood | 1 | Oncology & immunology | 1 | Meril |
| 3 | Chlorpromazine, 7-Hydroxy Chlorpromazine | Validated | 25 pg | Plasma | 2 | CNS & psychiatry | 1 | Emcure |
| 4 | Quetiapine | Validated | 1.0 ng | Plasma | 1 | CNS & psychiatry | 2 | Syrimed UK |
| 5 | Dapagliflozin, Telmisartan | Validated | 2.0 ng | Plasma | 2 | Cardiovascular & metabolic | 2 | Eris Lifescience Ltd |
| 6 | Pregabalin | Validated | 50.1 ng | Plasma | 1 | CNS & psychiatry | 1 | Syrimed UK |
| 7 | Famotidine | Validated | 1.0 ng | Plasma | 1 | Gastrointestinal | 1 | Syrimed UK |
| 8 | Candesartan | Validated | 2.0 ng | Plasma | 1 | Cardiovascular & metabolic | 1 | Syrimed UK |
| 9 | Vonoprazan, Levosulpiride, Domperidone | Validated | 200 pg | Plasma | 3 | Gastrointestinal | 4 | Eris Lifescience Ltd |
| 10 | Sertraline | Validated | 500 pg | Plasma | 1 | CNS & psychiatry | 1 | Orbit Pharma Limited, UK |
| 11 | Esaxerenone | Validated | 250 pg | Plasma | 1 | Cardiovascular & metabolic | 2 | Exemed Pharmaceuticals, Syrimed UK |
| 12 | Fludrocortisone | Validated | 30 pg | Plasma | 1 | Hormonal & endocrine | 1 | Syrimed UK |
| 13 | Bilastine | Validated | 2.0 ng | Plasma | 1 | Respiratory & allergy | 1 | M N Corporation - Bangladesh |
| 14 | Flecainide | Validated | 1.0 ng | Plasma | 1 | Cardiovascular & metabolic | 1 | Syrimed UK |
| 15 | Total ubiquinone (CoQ-10) | Validated | 30.0 ng | Plasma | 1 | Nutraceutical & other | 4 | ACG Capsules, Micillic |
| 16 | Dydrogesterone | Validated | 50 pg | Plasma | 1 | Hormonal & endocrine | 1 | M N Corporation - Bangladesh |
| 17 | Progesterone | Validated | 25 pg | Plasma | 1 | Hormonal & endocrine | 3 | Olive Pharmascience Ltd |
| 18 | Lacosamide | Validated | 25.0 ng | Plasma | 1 | CNS & psychiatry | 2 | Eris Lifescience Ltd |
| 19 | Paracetamol, Pseudoephedrine | Validated | 1.0 ng | Plasma | 2 | Analgesia & anti-inflammatory | 0 | — |
| 20 | Ibuprofen, Pseudoephedrine | Validated | 1.0 ng | Plasma | 2 | Analgesia & anti-inflammatory | 1 | Olive Pharmascience Ltd |
| 21 | Ibuprofen, Paracetamol | Validated | 50.0 ng | Plasma | 2 | Analgesia & anti-inflammatory | 1 | Olive Pharmascience Ltd |
| 22 | Cenobamate | Validated | 2.0 ng | Plasma | 1 | CNS & psychiatry | 1 | Eris Lifescience Ltd |
| 23 | Quetiapine (extended range) | Validated | 2.0 ng | Plasma | 1 | CNS & psychiatry | 0 | — |
| 24 | Pioglitazone, Metformin | Validated | 7.5 ng | Plasma | 2 | Cardiovascular & metabolic | 1 | Eris Lifescience Ltd |
| 25 | Caffeine, Paracetamol | Validated | 20.0 ng | Plasma | 2 | Analgesia & anti-inflammatory | 1 | Olive Pharmascience Ltd |
| 26 | Dapagliflozin, Metoprolol | Validated | 300 pg | Plasma | 2 | Cardiovascular & metabolic | 1 | Eris Lifescience Ltd |
| 27 | Ramipril, Ramiprilat | Validated | 200 pg | Plasma | 2 | Cardiovascular & metabolic | 1 | Syrimed UK |
| 28 | Ofloxacin, Ornidazole | Validated | 25.0 ng | Plasma | 2 | Anti-infective | 1 | Mankind Pharma Ltd |
| 29 | Mirtazapine | Validated | 500 pg | Plasma | 1 | CNS & psychiatry | 1 | Syrimed UK |
| 30 | Cyclizine | Validated | 200 pg | Plasma | 1 | Gastrointestinal | 2 | Syrimed UK |
| 31 | Paracetamol | Validated | 50.0 ng | Plasma | 1 | Analgesia & anti-inflammatory | 2 | Olive Pharmascience Ltd |
| 32 | Tolterodine | Validated | 50.0 ng | Plasma | 1 | Urology | 1 | Orbit Pharma Limited, UK |
| 33 | Dolutegravir, Emtricitabine | Dev complete | 18.8 ng | Plasma | 2 | Antiviral | 2 | Emcure |
| 34 | Tenofovir Alafenamide | Dev complete | 2.0 ng | Plasma | 1 | Antiviral | 2 | Emcure |
| 35 | Lenvatinib | Dev complete | 1.0 ng | Plasma | 1 | Oncology & immunology | 4 | Auxilla pharma |
| 36 | Rasagiline | Dev complete | 20 pg | Plasma | 1 | CNS & psychiatry | 1 | Emcure |
| 37 | Lurasidone | Dev complete | 200 pg | Plasma | 1 | CNS & psychiatry | 1 | Auxilla pharma |
| 38 | Oxcarbazepine, 10-OH-carbazepine | Dev complete | 10.0 ng | Plasma | 2 | CNS & psychiatry | 1 | Syrimed UK |
| 39 | Rosuvastatin | Dev complete | 50 pg | Plasma | 1 | Cardiovascular & metabolic | 0 | — |
| 40 | Ezetimibe, Ezetimibe glucuronide | Under dev | 50 pg | Plasma | 2 | Cardiovascular & metabolic | 1 | Syrimed UK |
| 41 | Cefuroxime | Under dev | 50.0 ng | Plasma | 1 | Anti-infective | 0 | — |
| 42 | Cefuroxime, Clavulanic Acid | Under dev | 25.0 ng | Plasma | 2 | Anti-infective | 2 | Mankind Pharma Ltd |
| 43 | Amoxicillin, Clavulanic Acid | Under dev | 25.0 ng | Plasma | 2 | Anti-infective | 2 | Mankind Pharma Ltd |
| 44 | Spironolactone | Under dev | 200 pg | Plasma | 1 | Cardiovascular & metabolic | 1 | Olive Pharmascience Ltd |
| 45 | Resmetirom | Under dev | — | Plasma | 1 | Hepatology & metabolic | 1 | Eris Lifescience Ltd |
| 46 | Tegoprazan | Under dev | — | Plasma | 1 | Gastrointestinal | 1 | Insignia |
| 47 | Aceclofenac, Paracetamol | Under dev | — | Plasma | 2 | Analgesia & anti-inflammatory | 2 | Mankind Pharma Ltd |
| 48 | Etoricoxib, Thiocolchicoside | Under dev | — | Plasma | 2 | Analgesia & anti-inflammatory | 1 | Mankind Pharma Ltd |
| 49 | Azithromycin | Under dev | — | Plasma | 1 | Anti-infective | 1 | Mankind Pharma Ltd |
| 50 | Dapagliflozin, Sacubitril, Valsartan | Under dev | — | Plasma | 3 | Cardiovascular & metabolic | 1 | Mankind Pharma Ltd |
| 51 | Edoxaban | Under dev | — | Plasma | 1 | Cardiovascular & metabolic | 1 | Stallion |
LLOQ is the lowest lower-limit-of-quantification across analytes in the method, normalised to a common unit. Therapeutic area is a derived pharmacological classification not present in the source documents. Study counts are cross-mapped from the master study list by molecule name and are indicative where product nomenclature differs between registers.
Molecules in studies with no method on file
| Product | Sponsor | Regulator | Note |
|---|---|---|---|
| Pyridostigmine 60 mg Tablets | Orbit Pharma Limited, UK | UKMHRA | Ongoing, due Aug-2026 |
| KSHN001034 & Fulvestrant | Kashiv | NA | Not in project tracker |
| Calcium carbonate / Vitamin D3 combinations | Eris Lifescience Ltd, Validus Lifescience | NA | Completed - non-LC-MS/MS endpoints |