Alcami is a world-class contract development and manufacturing organization (CDMO) with executive offices in Wilmington and Durham, North Carolina. Alcami is the first company to offer a solution that is tailored to small and mid-size pharmaceutical and biotechnology companies. Beyond that, we can integrate our services so customers experience a simplified engagement with a single project management relationship, full visibility from development into manufacturing, and shorter turnaround times. Our combined capabilities include:
- API development and manufacturing
- Analytical development
- Analytical testing
- Animal health
- Biologics
- Formulation development
- High-potency APIs
- Oral solid dose manufacturing
- Packaging and labeling
- Solid state chemistry
- Stability
- Sterile/parenteral manufacturing
Alcami offers an end-to-end outsourcing opportunity that can be integrated for a less fragmented, cost-effective, and faster pathway for products through the clinic toward commercialization, as well as individualized development and manufacturing services.
We make it easy for our partners to bring their products through the clinic to commercialization, embracing an approach that integrates our operations in a unique and highly effective way and where a product’s potential is turned into reality day-after-day. With a flexible and responsive approach, our Project Management group will help ensure the focus is always on the best possible outcome for your product at every level.
Alcami meets all applicable local, state, and federal regulatory requirements, including current GMPs and country guidelines for the United States, Canada, EU, and EU Member State regulatory bodies (e.g., EMA, MPA, IMB). We also incorporate international standards as part of the Quality Management System and meet expectations established by the USP, EP, and JP. We comply with all regulations and standards, including those regarding controlled substances (DEA), radioactive materials (NRC), environmental protection (EPA), child-resistant container-closures (CPSC), and employee safety (OSHA).
It is our goal to be the most efficient, safe, and reliable option to bring your product to market.
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