United Kingdom Europe
FDF / DRUG PRODUCTS CHEMICAL-SYNTHETIC in Europe
N/A
About the plant
We support drug development with small batch manufacturing services at all stages of the drug development process.
The Healthcare Technology Accelerator Facility (HTAF) is an MHRA certified contract manufacturing facility housed in the University of Edinburgh Institute for Regeneration and Repair. Based at Edinburgh BioQuarter we are ideally placed to support academic and commercial partners with bespoke small batch GMP manufacturing services.
https://healthcare-technology-accelerator.ed.ac.uk/
Compliance
- ICH
- EMA (EU GMP)
- FDA (cGMP)
- Health Canada (Canada GMP)
- NMPA (China GMP)
- TGA (Australia GMP)
- ANVISA (Brazil B-GMP)
- ANMAT (Argentina nueva GMP)
- MFDS/KFDA (Republic of Korea GMP)
- PMDA/MHLW (Japan GMP)
- ISP (Chile BPM)
- MHRA (UK GMP)
- ICHQ3A
- ICHQ3B
- ICHQ3D
- ICHQ1A
Activity
- Inhalation products, Oral liquids and semisolids, Sterile forms (ophtalmic, nasal, otic), Topical, mucosal and transdermal, Injectables, Nebulization, Bottles, Tubes, Sprays, Bulk, Oral solutions, Oral suspensions, Oral emulsions, Syrups, Oral gels, Fill&Finish, Dropper bottles, Semisolid forms, Liquid forms, Small volume vials, Large volume vials / Bottles, PFS (Prefilled Syringes), Flexible bags / Infusion systems, FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC, Intermediates, Fine Chemicals, API (Active Pharmaceutical Ingredients), Building Blocks manufacturing
Features
- Uses: Investigational, Preclinical, Phase I, 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)
- Controlled substance: High potential for abuse & medical use, Lower potential for abuse, Low potential for abuse, Lowest potential for abuse
- BSL: 1
- Therapeutic areas: (D) Dermatologicals, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (R) Respiratory system, (S) Sensory organs, (V04) Diagnostic agents
- Markets: FDA (USA), EMA (EU), PMDA (Japan), CDSCO (India), Health Canada (Canada), MHRA (UK), TGA (Australia), NMPA (China), ANVISA (Brazil), ANMAT (Argentina), MFDS (South Korea)
Batch Size / Reactor
- Small, 1 - 10 L
Services
- Regulatory services, Development services, Manufacturing services, Quality Assurance services, Packaging, Logistics, Preformulation studies, R&D, Formulation / Galenic design, Process development, Process optimization, Process validation, Stability studies design, Stability studies execution, ICH Stability studies, Comparability studies, Tech transfer, Research batches, Batch records, QP in house, Batch certification / release, GMP documentation, Primary packaging, Secondary packaging, Labeling, Storage, Distribution, CMC regulatory support, IND (Investigational New Drug aplication) filing support, IMPD (Investigational Medicinal Product Dossier) submission support, NDA (New Drug Application) submission support, DMF (Drug Master File) preparation and submission, Fill and finish, Customized block synthesis, Impurity synthesis
