Regulatory Services

PhACT provides professional regulatory advice and supports its clients in all fields related to marketing authorisation applications such as

• Registration strategy
• New or abbreviated marketing authorisation application, following either the centralised (CP), decentralised (MRP, DCP) or national procedure
• Renewal application
• Variation application (type IA/IB, type II, extension)
• Application for a Certificate of Suitability (CEP)
• Active substance master files (ASMF) procedure
• Preparing/accomanying authority meetings
• Pre-submission scientific evaluation of
  • quality documentation drug substance (chemical, biological) / drug product
  • bioequivalence/bioavailability studies for generic applications
• Technology transfer CMC (chemical and biological)

Any other regulatory support needed? Please contact us for a detailed and specific offer.