FDF / DRUG PRODUCTS in
Healios Labs is a specialty contract research and development laboratory (CRDO) based in New Jersey, USA that provides end-to-end pharmaceutical product development services. Topicals, Transdermals,...
Certifications
- EMA (EU GMP)
- FDA (cGMP)
- Health Canada (Canada GMP)
- NMPA (China GMP)
- TGA (Australia GMP)
- PMDA/MHLW (Japan GMP)
- MHRA (UK GMP)
Activity
- Implants, Inhalation products, Oral liquids and semisolids, Sterile forms (ophtalmic, nasal, otic), Topical, mucosal and transdermal, Injectables, BFS (Blow Fill Seal) ampolues, Small volume vials, Large volume vials / Bottles, Glass ampoules, PFS (Prefilled Syringes), Cartridges, Flexible bags / Infusion systems, FDF / DRUG PRODUCTS manufacturing
Features
- Uses: N/A
- Toxicity (OEB classification): N/A
- Controlled substance: N/A
- BSL: N/A
- Therapeutic areas: N/A
- Markets: FDA (USA), EMA (EU), PMDA (Japan), CDSCO (India), Health Canada (Canada), MHRA (UK), TGA (Australia), NMPA (China)
Batch Size / Reactor
- N/A
Services
- Regulatory services, Development services, Analytical / QC services, Quality Assurance services, Preformulation studies, Clean room rental, 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, Comparability studies, Analytical methods development, Analytical methods validation, Release testing of raw materials, Release testing of product, Bioanalysis, Analytical methods transfer, QP in house, Batch certification / release, GMP documentation, Parametric release, CMC regulatory support, IND (Investigational New Drug aplication) filing support, IMPD (Investigational Medicinal Product Dossier) submission 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, Orphan Drug Designation Support
