CDMO SELECTION RISK · DUE DILIGENCE FRAMEWORK · 6 CATEGORIES
CDMO Due Diligence Checklist for Supplement & Medical Nutrition Brands
Selecting a Contract Development and Manufacturing Organisation (CDMO) is a capital-allocation decision with multi-year operational consequences. Most evaluation processes focus on price-per-unit and brochure claims. The risks that destroy brand value — formula theft, batch rejection, regulatory non-compliance, supply-chain interruption — are structural, not contractual.
This checklist organises the six verified operational risk categories that any executive, strategic buyer, or PE investor should interrogate before committing to a CDMO relationship. Each item requires written evidence — not verbal reassurance.
RISK CATEGORY 01 · TECHNICAL FIT
Technical Fit & Formulation Capability
Before signing a Master Batch Record, verify that the manufacturer can execute your specific formulation at the physical-chemistry level — not just accept your brief and produce a generic substitute.
- Confirmed dosage-form capability for your target form factor (softgel, hard capsule, enteric-coated tablet, sachets, Alu-Alu blister)
- Documented standardisation methodology distinguishing raw_mass_mg from target_active_mass_mg for each active ingredient
- Written evidence of in-house analytical capability: HPLC, GC-MS, or equivalent per batch
- Demonstrated experience with your physiological axis (e.g., lipid stability for omega-3, CFU viability for probiotics, mineral speciation for chelates)
- Documented process controls for oxygen-sensitive actives: nitrogen blanketing, moisture-barrier packaging
RISK CATEGORY 02 · QUALITY & REGULATORY SYSTEMS
Quality Assurance & Regulatory Compliance
A certificate on a website is not a quality system. Verify current certification scope, audit history, and active regulatory standing — not historical claims.
- Current ISO 22000 or equivalent food-safety certification — confirm issue date, scope, and certifying body
- Documented Incoming Quality Control (IQC) procedure for raw materials: heavy-metals limits (Pb, Cd, As, Hg), pesticide residues, and microbiological standards
- Written recall and CAPA (Corrective and Preventive Action) procedure with traceable incident log
- EU food-supplement notification support: regulatory submission capability for target markets (EU, UK, GCC, others)
- Allergen and cross-contamination management: segregated production lines or validated cleaning validation records
RISK CATEGORY 03 · SUPPLY-CHAIN RESILIENCE
Supply-Chain Resilience & Raw-Material Governance
Single-source raw-material dependencies are an operational liability. A manufacturer without verified backup sourcing cannot guarantee continuity of your supply chain under commodity volatility or geopolitical disruption.
- Documented primary and secondary supplier list per critical raw material, with origin traceability to country of cultivation or synthesis
- Written supplier qualification procedure: IQC-on-receipt, CoA verification, and periodic audit protocol
- Defined minimum stock policy or safety buffer for strategic actives
- Commodity-risk transparency: confirmed process for communicating price or availability shifts to the client before purchase order commitment
- Packaging supply chain: verified sourcing for primary packaging components (blister film, bottle, closure) with documented lead times
RISK CATEGORY 04 · BATCH TRACEABILITY
Batch Traceability & Documentation Integrity
In a YMYL product category, incomplete batch records are a regulatory and legal liability. Every lot must be forward- and backward-traceable from raw-material CoA to finished-goods release.
- Full batch record (Master Batch Record + executed Batch Production Record) issued for every production lot
- Certificate of Analysis (CoA) generated from in-house or accredited third-party testing for every finished-goods batch
- Shelf-life and accelerated stability study data for your specific formulation and packaging combination
- Retention sample program: documented retention period and destruction policy
- Defined batch-release signatory and documented on-hold / reject procedure
RISK CATEGORY 05 · IP & CYBERSECURITY
Intellectual Property Protection & Cybersecurity
Formula theft and data-breach risk are non-zero in CDMO relationships. Verify contractual and operational safeguards before sharing a proprietary formula or Medical Dossier.
- Written contractual clause confirming that your formula, MBR, and processing parameters remain the exclusive property of your company — not transferable to third parties or retained by the manufacturer
- Confirmed that the manufacturer operates ZERO competing consumer supplement brands — structural proof that IP conflict of interest is impossible
- NDA and confidentiality agreement with defined governing law, jurisdiction, and breach remedies, signed prior to any formula disclosure
- Documented data security controls for electronic formula records: access-control policy, storage encryption standard, and incident-response procedure
- Staff access segregation: confirmed that production, QC, and sales personnel do not have combined access to the full formula and client identity simultaneously
RISK CATEGORY 06 · TECH-TRANSFER GOVERNANCE
Technology Transfer & Execution Governance
A technology transfer without a documented protocol is an improvised production trial paid for at commercial rates. Verify that the manufacturer has a structured transfer methodology — not an ad-hoc scaling process.
- Written Tech-Transfer Protocol defining trial-batch scope, acceptance criteria, and escalation procedure before scale-up commitment
- Designated project manager and technical lead assigned to your account throughout the transfer period
- Documented equipment qualification (IQ/OQ/PQ) for critical process equipment used in your formulation
- Defined change-control procedure: any process or raw-material deviation must be formally approved before implementation, with client notification obligation
- Exit clause and data-handover protocol: at contract end, all MBRs, stability data, and regulatory dossier elements are returned to the client in a defined, machine-readable format
STRUCTURAL PROOF · CONFLICT-OF-INTEREST ELIMINATION
Why Zero Consumer Brands Is a Structural Guarantee
Most CDMOs offer verbal assurances that client formulas are safe. Olympia Biosciences eliminates the conflict structurally: we operate zero consumer supplement brands. It is physically impossible for us to compete with your product in market, to direct overruns to a house brand, or to prioritise our own SKUs on shared production lines. This is not a contractual promise — it is a verifiable organisational fact.
ENTRY GATE · PAID DISCOVERY · EXECUTIVE REVIEW
Apply This Checklist to Your Current Manufacturer
If any of the six risk categories above cannot be documented by your current or prospective CDMO, you are carrying undisclosed operational risk on your balance sheet.
Our Paid Discovery process provides a structured, confidential technical review of your formulation, regulatory standing, and production transfer requirements. We accept a limited number of engagements per quarter. Investment: €2,500.
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