Clinical Manufacturing

Regulatory Support

Guiding you through regulatory submission and approval

We support you in all regulatory phases for both new market entrants and established products. Our in-depth knowledge of global regulatory requirements will help you with regulatory documents that are needed for both clinical studies as well as marketing authorizations for registration:

Clinical phases:

  • Investigational New Drug (IND) Applications
  • Investigational Medicinal Drug Dossier (IMPD)

Product submission:

  • New Drug Application (NDA)
  • Biologic License Application (BLA)
  • Marketing Authorization Application (MAA)
  • Common technical Document (CTD)

Documentation and submission support

Our regulatory Chemistry, Manufacturing, and Control (CMC) experts are well versed in the informational requirements, submission formats, and approval processes of various authorities.

We’ll work with you to guide and streamline your preparation of the CTD necessary for clinical submission and market authorizations.

Regulatory inspections

Vetter undergoes routine regulatory inspections and our facilities meet the stringent requirements of authorities around the globe. This includes routine GMP and pre-approval inspections, either on-site or paper-based.

Contact us

How can we help? We offer extensive contract development and manufacturing expertise. To discuss your next project or request more information, connect with us.

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