Cpk > 1.33
Process Capability
PPQ-qualified reproducibility at commercial volume
Enterprise Scale-Up CDMO · Execution Intelligence
Scale-Up for Brands That Cannot Afford Variability.
When your valuation depends on execution, production theater is worthless. We deliver evidence-based scale architecture. Board-ready controls, analytical release certainty, and disciplined transfer logic are non-negotiable.
17 Yrs · 0
Quality Complaints
Institutional QA record across enterprise programs
HPLC/GC-MS
Batch Release Analytics
Every run released on analytical evidence, not assumptions
100M+/month
Industrial Throughput
Three independent softgel lines with technical redundancy
The Velvet Rope
Selective Admission Protects Outcome Quality.
We refuse mandates that are not ready for evidence-led execution. Selectivity safeguards the integrity of every active program and removes avoidable failure modes before they enter production.
- You are scaling a serious brand asset, not testing discount-market demand.
- You require defensible quality proof for boards, regulators, clinics, or investors.
- You expect documentation discipline that survives diligence and transfer.
- You are prepared to enter via Initiate R&D Due Diligence (paid).
Scale Protocol
Reproducibility Is the Product.
Capacity is easy to advertise. Controlled consistency at enterprise volume is hard to execute. Our scale-up method prioritizes process capability, analytical certainty, and transfer-grade documentation from day one.
Validation Standard
PPQ pathway with Cpk > 1.33 targets
Release Criteria
HPLC/GC-MS analytical sign-off
Operational Continuity
3 independent lines, 300% technical redundancy
Governance
ISO 27001 + zero-conflict operating model
Diligence Outcomes
What Admission Actually Gives You.
-
A scale-up route engineered for compliance resilience, not quote velocity.
-
Operational documentation that survives board review and acquirer scrutiny.
-
An execution partner aligned to quality outcomes before production economics.
Execution Ladder
Four Moves from Pilot Promise to Enterprise Repeatability.
01
Admission Diligence
Technical triage determines scientific fit and scale-risk exposure before acceptance.
02
Process Architecture
We design quality-critical controls for reproducibility and compliance stability.
03
PPQ Validation
Qualification runs prove capability before full commercial deployment.
04
Industrial Campaigns
Enterprise volume production under analytical release and transfer-ready documentation.
Final Gate
Initiate R&D Due Diligence.
If your mandate is to build a defensible, acquisition-grade supplement platform, we can evaluate fit. If your mandate is low-friction quote shopping, this gate is intentionally closed.
Trust metrics: Cpk > 1.33 | 17 Yrs · 0 Complaints | HPLC/GC-MS
Frequently Asked Questions
Why gate scale-up projects behind paid due diligence?
Because scale-up failure is expensive. We map formulation risk, process capability, and compliance pathways before acceptance. Paid due diligence filters out speculative briefs and protects execution quality for admitted partners.
What is validated during your scale-up admission process?
We evaluate ingredient-system behavior, process sensitivity, quality-critical parameters, and analytical release strategy. Admitted projects receive a technical route designed for PPQ-level reproducibility, not trial-and-error production.
Can enterprise QA teams audit your manufacturing and controls?
Yes. Qualified teams can audit clean-room operations, CAPA framework, batch records, and laboratory controls in Gdynia. We encourage independent verification because institutional trust is earned with evidence.
How do you maintain consistency at high production volume?
Through PPQ-guided process control, in-process monitoring, and analytical release on HPLC/GC-MS. We optimize for repeatable output quality at scale, not headline throughput without capability discipline.
Who owns the formulation intelligence and process documentation?
The client does. We contract and operate with explicit IP-security principles, including transfer-ready documentation for long-term continuity and strategic transactions.
What happens if a project is not admitted after due diligence?
You receive a clear technical decision memo with the limiting factors and risk signals identified. We do not accept borderline projects that would compromise quality outcomes for either side.
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Strictly B2B / Educational R&D Disclaimer
The pharmacokinetic data, clinical references, and scientific literature referenced on this page are provided strictly for B2B formulation, educational, and R&D purposes for medical professionals, pharmacologists, and brand developers. Olympia Biosciences™ operates solely as a Contract Development and Manufacturing Organization (CDMO) and does not manufacture, market, or sell consumer end-products.
Global Regulatory & No Health Claims. Nothing on this page constitutes a health claim, medical claim, or disease-risk-reduction claim within the meaning of EU Regulation (EC) No 1924/2006, the U.S. Dietary Supplement Health and Education Act (DSHEA), or other global regulatory frameworks. These statements and raw data have not been evaluated by the Food and Drug Administration (FDA), European Food Safety Authority (EFSA), or Therapeutic Goods Administration (TGA). The raw active pharmaceutical ingredients (APIs) and formulations discussed are not intended to diagnose, treat, cure, or prevent any disease.
Client Responsibility. The B2B client who commissions a formulation from Olympia Biosciences™ bears full and sole responsibility for all regulatory compliance, health claim authorization (including EFSA Article 13/14 claim dossiers and U.S. FDA notifications), labeling, and marketing of their finished product in their target market(s). Olympia Biosciences™ provides manufacturing, formulation, and analytical services only.