Sentio Biosciences llc
Sentio Biosciences LLC operates as a Contract Manufacturing Organisation (CMO) and Contract Development and Manufacturing Organisation (CDMO) for the pharmaceutical industry.
Description
Sentio Biosciences LLC operates as a Contract Manufacturing Organisation (CMO) and Contract Development and Manufacturing Organisation (CDMO) for the pharmaceutical industry. The company provides a comprehensive range of services encompassing research and development, pilot, clinical, and commercial manufacturing of both new and generic products. Sentio Biosciences is distinguished by its vertical integration capabilities, spanning from the manufacture of key starting materials (KSM) to the production of finished drug products. They specialise in the characterisation and analytical method development of pharmaceuticals, ensuring ongoing testing and stability studies for new products. Additionally, the company is adept at regulatory filings including Chemistry, Manufacturing and Controls (CMC), Drug Master Files (DMFs), New Drug Applications (NDA), Abbreviated New Drug Applications (ANDA), New Animal Drug Applications (NADA) and Abbreviated New Animal Drug Applications (ANADA). Their expertise extends to providing commercial product regulatory support, catering to a diverse product range that includes non-toxic, toxic, and high-potent products.
Services include:
- APIs (Active Pharmaceutical Ingredients)
- Finished Dosage Forms
- Medical Devices
- R&D (Research and Development)
- Pilot, Clinical, and Commercial Manufacturing
- Vertical Integration from KSM to Drug Products
- Characterisation
- Analytical Method Development
- Ongoing Testing
- Stability Studies for New Products and Ongoing
- Regulatory Filing CMC
- DMFs
- NDA
- ANDA
- NADA
- ANADA
- Commercial Product Regulatory Support
Sentio Biosciences LLC embodies a holistic approach to pharmaceutical manufacturing, underpinned by a commitment to quality and compliance. For more information, please visit sentiobiosciences.com.