United States North America
FDF / DRUG PRODUCTS in North America
Research and Development Services, Analytical Services, Technology Transfer and New Product Introduction, and Manufacturing Services in the field of solid and liquid oral dosage forms.
About the plant
Client First CDMO: Quality-driven, US-based CDMO offering concept-to-commercialization services, including Research and Development Services, Analytical Services, Technology Transfer and New Product Introduction, and Manufacturing Services in the field of solid and liquid oral dosage forms.
Certifications
- ISO
- FDA (cGMP)
- World Health Organization (GMP / HACCP)
Activity
- Oral liquids and semisolids, Oral solids / OSD, Bottles, Oral solutions, Oral suspensions, Oral emulsions, Syrups, Tablets, Hard capsules, Granules / Pellets, FDF / DRUG PRODUCTS manufacturing
Features
- Uses: Investigational, Commercial (Phase IV), Preclinical, Phase I, Phase II, Phase III, Human
- Toxicity (OEB classification): 3 (PDE = 100 - 1,000 µg/day)
- Controlled substance: N/A
- BSL: 1
- Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and blood forming organs, (C) Cardiovascular system, (D) Dermatologicals, (G) Genito urinary system and sex hormones, (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (S) Sensory organs, (V06) Nutrients, (V04) Diagnostic agents, (V01) Allergens
- Markets: FDA (USA)
Batch Size / Reactor
- Small, Medium, Large
Services
- Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Logistics, Preformulation studies, R&D, Formulation / Galenic design, 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, Formulation mixing, 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, Primary packaging, Secondary packaging, Storage, GDP, CMC regulatory support, IND (Investigational New Drug aplication) filing support, NDA (New Drug Application) submission support, ANDA (Abbreviated New Drug Application) submission support, CTD/eCTD compilation and submission, DMF (Drug Master File) preparation and submission
