Successfully expanding your business into the European market requires expert navigation of complex regulatory hurdles. PGF Pharma International’s dedicated Regulatory Affairs team possesses the competence to ensure a swift and smooth registration process. We provide diligent oversight and strategic management for your product throughout its entire lifecycle.

Our Comprehensive Regulatory Services:

Marketing Authorization Application (MAA):

• Expert preparation and submission of MAAs for medicinal products within the EU.
• Compilation of necessary documentation, including Readability User Testing (RUT) reports and Bridging Reports.
• Management of eCTD sequence submissions.

Regulatory Procedures & CMC:

• Ongoing management of regulatory procedures post-submission and post-approval.
• Specialized Chemistry, Manufacturing, and Controls (CMC) services and support.

Product Lifecycle Management:

• Proactive handling of post-approval activities, including variations and renewals.
• Labeling and artwork development, review, and management.

Specialized Regulatory Support:

• Local Representation (Croatia): Acting as your local regulatory representative in Croatia, including due diligence services for MA dossiers.
• Medical Devices: Dedicated regulatory management for medical devices.
• Other Product Categories: Regulatory oversight and compliance support for food supplements and cosmetic products.