EU-Regulated Clinical Nutrition Manufacturing
EU-Regulated FSMP & Clinical Nutrition Contract Manufacturing
Olympia Biosciences™ is a specialized European CDMO for Foods for Special Medical Purposes (FSMP), operating under EU Delegated Regulation 2016/128 since 2009. We deliver pharmaceutical-grade clinical nutrition formulations for oncology, metabolic disorders, and post-surgical recovery — with complete regulatory documentation for EU and global market access.
What Is FSMP and Why Does It Require Specialized Manufacturing?
Foods for Special Medical Purposes (FSMP) — known as "medical food" in the US regulatory framework — are a distinct product category designed for the dietary management of specific diseases, disorders, or medical conditions. Unlike standard dietary supplements, FSMP products are intended to be used under medical supervision and must meet stringent compositional requirements defined by EU Regulation 609/2013 and the EU Delegated Regulation 2016/128.
Manufacturing FSMP products demands capabilities that go far beyond standard supplement production. The formulations must deliver precise nutritional profiles tailored to specific pathological states — whether oncology-related cachexia, metabolic disorders, renal insufficiency, or neurological conditions requiring ketogenic nutrition. This is evidence-based medicine (EBM) supplement manufacturing at its most demanding.
Our FSMP Manufacturing Capabilities
Olympia Biosciences™ has developed specialized production protocols for FSMP and medical food manufacturing that bridge the gap between pharmaceutical manufacturing and food production. Our capabilities span the full spectrum of clinical nutrition products:
Oncology Nutrition FSMP
Glycolysis-restricted, zero-carbohydrate formulations for patients exhibiting the Warburg phenotype. Precision lipid encapsulation with advanced taste-masking for severe dysgeusia. High-density caloric delivery without insulin stimulation.
Metabolic & Ketogenic FSMP
Precision ketogenic formulations delivering alternative cerebral energy substrates. Microencapsulated MCT/C8 matrices with gastric-bypass technology for patients with cerebral glucose hypometabolism.
Post-Surgical & Recovery FSMP
High-bioavailability nutrient matrices designed for patients with compromised digestive function. Gentle, micronized formulations that bypass standard gastric processing challenges.
Evidence-Based Medicine (EBM) Supplement Manufacturing
Every FSMP formulation developed by Olympia Biosciences™ is grounded in published clinical evidence. Our R&D process begins with a systematic review of relevant clinical literature. Our scientists then design each formulation from scratch, optimizing ingredient selection, dosage ratios, and delivery mechanisms based on pharmacokinetic data. As an additional verification step — adopted from pharmaceutical drug development — our proprietary AI system screens every formula for interaction risks, cocktail effects, and toxicological concerns. This extra layer of safety is what separates clinical-grade manufacturing from standard supplement production.
The result is science-backed supplement production that can withstand scrutiny from physicians, regulatory authorities, and clinical trial reviewers. Every formulation is accompanied by a comprehensive R&D dossier documenting the evidence base, formulation rationale, and analytical verification data.
Pharmaceutical-Grade Supplement Manufacturing
FSMP production at Olympia Biosciences™ operates under pharmaceutical-grade manufacturing protocols. This means ISO 22000 food safety management, ISO 9001 quality management, GMP/HACCP compliance, and HPLC/GC-MS analytical verification of every batch. Our zero-complaint track record over 17 years of operation reflects the consistency and reliability that medical food manufacturing demands.
For brands and investors entering the FSMP space, we provide complete regulatory support including EU Delegated Regulation 2016/128 compliance, EFSA-compliant labeling, GIS notification, and export documentation for international markets. Our clinical-grade supplement contract manufacturing capabilities ensure that your FSMP product meets the highest regulatory standards from day one.
Medical Food Manufacturing for Global Markets
The regulatory landscape for medical foods varies significantly between jurisdictions. In the EU, FSMP is governed by specific delegated regulations under the broader food law framework. In the US, medical foods fall under FDA oversight with distinct labeling and claims requirements. Olympia Biosciences™ navigates both regulatory environments, providing dual-compliant formulations and documentation that enable global market access from a single production source.
Our Pledge
We do not own consumer brands. We never compete with our clients.
Every formula created at Olympia Biosciences™ is built from scratch and transferred to you with full intellectual property ownership. Zero conflict of interest — guaranteed by ISO 27001 and iron-clad NDAs.
Develop Your FSMP or Medical Food Product
Pharmaceutical-grade FSMP contract manufacturing with evidence-based formulation and complete regulatory support.
Request an FSMP Feasibility AuditFrequently Asked Questions
What is FSMP and how does it differ from regular dietary supplements?
Does Olympia Biosciences™ manufacture FSMP for international markets?
What analytical methods does Olympia Biosciences™ use for FSMP quality control?
What FSMP categories can Olympia Biosciences™ manufacture?
What EU regulatory framework governs FSMP manufacturing?
Can Olympia Biosciences™ manufacture FSMP in softgel capsule form?
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.