Regulatory

Phax Pharma specialises in regulatory services for pharmaceuticals and active ingredients.

Preparation of regulatory documents and productive scientific advice meetings are essential in successful product development and marketing authorisations

With our experience in the assessment and preparation of Marketing Authorisation submissions, Drug Master Files, Certificates of Suitability and securing regulatory approvals we are well versed in the requirements for the completion of regulatory documents.

And having been on both sides of the table it provides us with a unique perspective on what is needed, and what can be achieved from scientific advice meetings with the MHRA, EMA and FDA.

Regulatory Documentation

• Common Technical Document modules
• Regulatory responses
• Orphan drug designations
• Clinical Trial Applications
• Traditional herbal registrations

Scientific Advice Meetings

• Preparation of briefing documents
• Representation at meetings
• Management of the process
• Communication with authorities

Active Ingredients

• Drug Master Files
• Certificate of Suitability applications
• Regulatory responses