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Softgel CDMO · Strategic Manufacturing Intelligence

Medical-Grade Softgel Manufacturing for Strategic Leaders Building Category Authority.

This is not commodity production. We engineer defensible softgel systems with validated process capability, analytical certainty, and board-level IP protection. If your strategy is price arbitrage, this page is not for you.

Initiate R&D Due Diligence Review Formula Security Protocol

Cpk > 1.33

PPQ Process Capability

Pharma-grade reproducibility at industrial scale

17 Yrs · 0

QA Complaints

Operational record since 2009

HPLC/GC-MS

Release Verification

Every batch analytically released

ISO 27001

Formula Security

Zero-conflict data governance

The Velvet Rope

Admission Is Selective by Design.

We reject mandates that cannot support scientific rigor, regulatory discipline, and enterprise execution standards. Selectivity is not branding — it is quality control for everyone already inside the portfolio.

  • You are protecting a clinical evidence thesis, not launching a commodity SKU.
  • You need defensible formulation IP for valuation, clinical authority, or strategic transfer.
  • Your team can execute enterprise manufacturing discipline, not price-first purchasing.
  • You are prepared to start with Initiate R&D Due Diligence (paid).

Evidence Protocol

Reproducibility Before Throughput.

Our rotary die operation is governed by PPQ thresholds, in-process controls, and release analytics that satisfy technical diligence standards. Capacity exists, but capability is the point.

Process Control

Cpk > 1.33 validation threshold

Analytical Release

HPLC/GC-MS per-batch verification

Continuity

3 independent rotary die lines

Governance

ISO 27001 + Zero-Conflict mandate

Strategic Outcomes

What You Actually Acquire.

  • A formulation architecture engineered for clinical credibility and commercial defensibility.

  • A documented scale-up route that survives quality, investor, and acquirer scrutiny.

  • An IP asset that remains exclusively yours under enforceable transfer and security controls.

Execution Ladder

Four Moves from Scientific Thesis to Industrial Dominance.

01

Due Diligence Intake

We assess strategic fit, scientific defensibility, and regulatory complexity before admission.

02

Formulation Architecture

R&D defines dosage form, ingredient system, and quality-critical parameters.

03

Validation & PPQ

Pilot and qualification runs establish reproducibility with measurable process capability.

04

Industrial Deployment

Scale campaigns proceed under controlled analytics and transfer-grade documentation.

Final Gate

Initiate R&D Due Diligence.

If your objective is to build an acquisition-grade medical asset with defensible outcomes, we should evaluate fit. If your objective is a cheap quote, this is the wrong institution.

Initiate R&D Due Diligence Audit Scale-Up Architecture

Trust metrics: Cpk > 1.33 | 17 Yrs · 0 Complaints | HPLC/GC-MS

Frequently Asked Questions

How does Olympia softgel manufacturing differ from standard supplement factories?
We do not run a catalog model. Every admitted project is engineered from first principles with PPQ-controlled scale-up, HPLC/GC-MS release analytics, and formal IP transfer protocols under ISO 27001 governance.
Why is due diligence paid instead of free?
Because we perform actual technical work before acceptance: dosage-form feasibility, interaction risk framing, process architecture, and regulatory route selection. Free quotes optimize sales velocity; paid due diligence optimizes execution quality.
What does the paid due diligence include?
It includes executive scientific triage, formulation route analysis, transfer-risk mapping, and a formal admission decision. If admitted, the outcome becomes the operational blueprint for R&D and industrial scale-up.
Can enterprise teams audit your softgel operation?
Yes. Qualified teams may audit clean-room controls, analytical workflows, CAPA structure, and scale-up documentation in Gdynia. We prefer third-party verification over marketing narratives.
What production range can be supported after admission?
Programs typically begin with controlled validation runs and expand into high-throughput campaigns on three independent rotary die lines. The objective is not volume theater; the objective is repeatable therapeutic consistency at scale.
Who owns the final formula and process intelligence?
You do. Ownership transfer is contractual and technical, including structured documentation necessary for enterprise continuity and transaction-grade diligence.

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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.