FDF / DRUG PRODUCTS in Europe

FDF / DRUG PRODUCTS in Europe

A GMP facility fully equipped for R&D and pharmaceutical development. Includes laboratories and a pilot plant for technical and clinical batches of sterile...

About the plant

1. Formulation, Process & Device Department

• Expertise in Controlled Release Formulations (CRF) and Ultra High Compositions (UHC) for small molecules, peptides, and biologics such as proteins or monoclonal antibodies (mAbs).
• Preformulation and formulation development to create ready-to-use (RTU) solutions tailored to specific needs.
• Platform technology for analyzing physicochemical properties of APIs and excipients, supporting the development of various technologies: In situ forming or pre-formed depot implants, highly concentrated suspensions, aqueous compositions, hydrogels, biodegradable implants and microparticles, and very low molecular weight polymers.

2. Analytical and Phy-Chem Department

• Stability studies and quality control during the development process.
• Advanced analytical characterization of formulations.

3. GMP Pilot Plant: Production of GMP clinical batches for Phase 1 and Phase 2.

• Freeze-dried products (aseptic process).
• Small volume liquids (terminal sterilization and aseptic process).
• Semisolids (terminal sterilization).
• Process scaling and validation for formats such as vials, syringes, and cartridges.

4. Regulatory, QA, and Clinical Department

• GMP Oversight: Management of activities, batch release, and regulatory authority interactions.
• Quality Assurance: Quality system management and internal/external audits.
• Clinical Support: Documentation management, clinical trials, and coordination with CROs.

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Certifications

• EMA (EU GMP)

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Activity

• Implants, Oral liquids and semisolids, Sterile forms (ophtalmic, nasal, otic), Injectables, Terminal sterilization, Fill&Finish, Small volume vials, PFS (Prefilled Syringes), Cartridges, FDF / DRUG PRODUCTS manufacturing

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Features

• Uses: Investigational, Preclinical, Phase I, Phase II, Human, Veterinary
• Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
• DEA: N/A
• BSL: 1, 2
• Therapeutic areas: N/A
• Markets: EMA (EU)

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Batch Size / Reactor

• Small

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Services

• Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Preformulation studies, R&D, Formulation / Galenic design, QbD (Quality by Design), Process development, Process optimization, Process validation, Lyophilization cycle development, Stability studies design, Stability studies execution, ICH Stability studies, Tech transfer, Pilot plant, Formulation mixing, Lyophilization, Research batches, Engineering batches, Scale-up, Pilot batches, Batch records, Analytical methods development, Analytical methods validation, Release testing of raw materials, Release testing of product, Analytical methods transfer, Batch certification / release, GMP documentation, CMC regulatory support