Controlled Substance Manufacturing

Bridging Studies For Producer Cell Line Adoption: Regulatory And Development Perspectives

Explore how analytical comparability, risk assessment, and bridging strategies can support a smooth and compliant platform transition.

Strategic CDMO Partnerships Begin By Unraveling The Complexities

Selecting the right CDMO is critical for pharmaceutical sponsors. To avoid pitfalls, sponsors should evaluate a CDMO's capacity, technical capabilities, quality metrics (like CAPA effectiveness and deviation times), financial stability, and talent retention. Establishing strong communication, supply chain transparency, and routine quality audits also helps ensure a successful, long-term partnership.

Novasep

Novasep brings innovative solutions to complex challenges within the life science industries for the production of synthetic molecules and biomolecules.

Paragon BioServices, Inc.

Founded in 1990, Paragon Bioservices is a CMC Center of Excellence delivering research, development and cGMP manufacturing services to pharmaceutical companies, biotechnology companies and federal agencies

 

PYRAMID Laboratories, Inc.

PYRAMID Laboratories, Inc. (PYRAMID), established in 1988, is located in Southern California, USA. Our facilities are housed in three (3) buildings covering approximately 70,000 sq. ft.

Recipharm AB

Recipharm is one of Europe’s leading pharmaceutical Contract Development and Manufacturing Organisations (CDMO).

Roche Custom Biotech

With over 50 years of biotechnology experience, a worldwide presence, and strong customer orientation, Roche Custom Biotech is uniquely positioned to supply the Diagnostics, Pharma, and Biotech industry with products and services, customized to your quality and regulatory needs.

Wet Nanomilling And Vial Filling

Nanomilling revolutionizes drug delivery by reducing particle size to enhance solubility, bioavailability, and therapeutic efficacy, addressing the challenges of poorly water-soluble APIs.

Solutions For Injectables And Parenteral Formulations

Sterility is key for high-risk applications such as injectables, parenteral formulations, ophthalmic and peritoneal dialysis solutions, and many more.