Manufacturing & Regulatory Support

B2S Consulting offers consulting services for the pharma / biotech industries. We have deep expertise in all aspects of process development and technology transfer for finished product manufacturing, as well as support for site inspections and FDA responses.

Furthermore, our services include technical writing and compilation of all CMC-related aspects of regulatory submissions and communications. Management support services include screening, auditing, selecting and managing contract manufacturing organizations, and performing project management duties associated with CMC-related tasks.

Services that may be applied to the needs of start-up, clinical development, or commercial organizations include:

Process Development

  • Process design, finished product manufacturing: formulation, filling, and freeze drying for sterile product manufacture
  • Technology transfer to manufacturing (GMP); preparation for site inspections

Technical Writing, Regulatory Communication

  • Write and compile CMC sections of regulatory communications (briefing documents, IND, NDA)
  • Write technical sections for regulatory communications or presentations to investors and Boards involving development of drugs, biologics, or combination products

Management

  • Project management; have directed multi-organization and international teams to successfully complete CMC sections for regulatory submissions (US and Europe)
  • Selection and management, contract manufacturing organizations
B2S Life Sciences