Accelerate biotechnology

Manufacturing & Regulatory Support

In addition to process development, product manufacturing and product characterization, we offer expert manufacturing and regulatory support in translating processes into regulatory dossiers.

Our experienced staff offers their support in the preparation of the CMC section of the IND or IMPD and in meetings with the regulatory authorities.

Utilizing our SCOUT® technology, we can establish downscale models of your manufacturing process that can be used to screen critical raw materials or test vendors without risking interruption to your manufacturing process.

Our experts would be happy to advise you on the best solution for your project

Virus & Cell banking

Clinical Manufacturing

GMP Release