FDA and Health Product Regulatory

CDMO, Manufacturing, and Supply Chain Agreements

Morningstar advises pharmaceutical, biotechnology, medical device, consumer health, and other life sciences companies, as well as contract development and manufacturing organizations (CDMOs), on the agreements that support product development, manufacturing, supply chain management, and commercialization.

Developing and manufacturing a new health product for commercialization usually entails negotiation of multiple complex agreements. Morningstar Law Group has experienced FDA and health product regulatory and life sciences lawyers who can craft and negotiate these agreements, giving particular care and attention to intellectual property, financial, and compliance-related risks.  Our attorneys are veteran negotiators with a lengthy track record of successfully closing development, manufacturing, and supply deals for manufacturers and contract development and manufacturing organizations (CDMO).

A sampling of the type of agreements our attorneys can assist you with includes:

  • Commercial product manufacturing and supply agreements
  • Product development services agreements
  • Tech transfer services agreements
  • Active pharmaceutical ingredient (API) supply agreements
  • Quality agreements
  • Packaging and labeling services agreements
  • Distribution services agreements