Photo showing two people discussing regulatory challenges and complexities when manufacturing and working with the manufacturing of biologics and large molecules

Clinical BioManufacturing

Regulatory Support

Biologics product development requires navigating complex and often-changing regulatory challenges that vary with each part of the product's lifecycle and differ greatly from the regulations faced by those developing traditional pharmaceuticals.

Scorpius BioManufacturing takes a proactive approach to meeting these regulatory requirements. We work closely with CDMO clients to develop effective regulatory drug development strategies for advanced biological therapies from the earliest stages of product development through to market authorization.

With a robust team of regulatory experts, Scorpius BioManufacturing is well-equipped to support your product as it is developed, manufactured, and brought to market. Our staff is experienced with a number of different global regulatory agencies including the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and Japan's Pharmaceuticals and Medical Devices Agency (PMDA).

They are prepared not only to evaluate and guide regulatory strategy, but also to represent clients in their interactions with regulatory bodies such as the FDA. You can feel secure knowing that Scorpius BioManufacturing's experts will act as guides and advocates as we work together to navigate any regulatory challenges that may arise during your product's manufacture and beyond.

Regulatory Support Services

Our regulatory support service offerings are designed to ensure a smooth path for your biologics product at every stage and scale.

Our regulatory support services include:

  • Evaluation and guidance of regulatory strategy for the development of biologics products
  • Representation of clients in interactions with FDA or other regulatory agencies
  • Authorship and review of CMC materials for regulatory applications and submissions
  • Leveraging experience with global regulatory agencies including the FDA, EMA and PMDA
Food and drug administration logo representing Scorpion's support with regulation around cell and gene therapy contract manufacturing
European medicines agency logo representing Scorpion's CDMO support with regulation around biologics contract manufacturing
PMDA logo representing Scorpion's global regulatory support in the large molecule manufacturing space

Learn more about our commitment to using American-made cGMP-compliant equipment and consumables to find out how we can work with you to develop an optimized formulation for your biologics project.