CHEMICAL-SYNTHETIC SERVICES in Europe
Small-molecule API CDMO providing process development, scale-up, analytical support, and EU GMP manufacturing services for pharmaceutical and biotech companies.
About the plant
TBD Pharmatech is an Estonian contract development and manufacturing organisation specialising in small-molecule active pharmaceutical ingredients, advanced intermediates, and fine chemicals. The company supports pharmaceutical and biotech partners with route scouting, process development, analytical method development, scale-up, technology transfer, regulatory support, and GMP manufacturing. TBD Pharmatech operates EU GMP-certified facilities in Tartu, Estonia, and serves projects from early development through clinical and commercial supply. The company has contributed to the pharmaceutical industry since 2006 and has operated under GMP compliance since 2008.
Compliance
- ICH
- ISO
- EMA (EU GMP)
- 9001
- ICHQ3A
- ICHQ3B
- ICHQ1A
- ICHM7
Activity
- CHEMICAL-SYNTHETIC, SERVICES, Intermediates, Fine Chemicals, API (Active Pharmaceutical Ingredients) manufacturing
Features
- Uses: Investigational, Preclinical, Phase I, Phase II, Phase III, 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: Lower potential for abuse, Low potential for abuse, Lowest potential for abuse
- BSL: N/A
- Therapeutic areas: (A) Digestive tract and metabolism, (C) Cardiovascular system, (D) Dermatologicals, (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (V04) Diagnostic agents
- Markets: N/A
Batch Size / Reactor
- Small, Medium, 1 - 10 L, 10-100 L, 100 - 1,000 L
Services
- Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, R&D, QbD (Quality by Design), Process development, Process optimization, Process validation, Stability studies design, Stability studies execution, ICH Stability studies, Comparability studies, Tech transfer, Pilot plant, Research batches, Engineering batches, Scale-up, Pilot batches, Registration batches, Batch records, Analytical methods development, Analytical methods validation, Release testing of raw materials, Release testing of product, Analytical methods transfer, QP in house, Batch certification / release, GMP documentation, Parametric release, CMC regulatory support, IND (Investigational New Drug application) filing support, IMPD (Investigational Medicinal Product Dossier) submission support, NDA (New Drug Application) submission support, CTD/eCTD compilation and submission, DMF (Drug Master File) preparation and submission, Crystallization screening, Milling, Safety studies, PGI assessment (Genotoxic Impurities), Customized block synthesis, Impurity synthesis, Stability tests, Identity, Content, Purity / Potency, Impurities, Physicochemical characterization, Water content (KF), Residual solvents (GC-MS), API / Excipient – Liquid, API / Excipient – Solid
