Regulatory Submissions

Our understanding of the intricacies and processes of regulatory agencies is unsurpassed. Whether, you are a large pharmaceutical company that needs to outsource a single regulatory submission, a small or virtual biotech company with limited regulatory affairs resources, or a dietary supplements manufacturer with a submission that does not seem to fit into a regulatory box. IPA Consulting Services can help.

Skill sets aside, the integrity, responsiveness, and character of our team speaks for itself. Our regulatory specialist are focused on the strategic and operational aspects of regulatory affairs by developing regulatory strategies and compliance requirements, interpreting regulations, and writing and reviewing submissions. They have detailed knowledge of the applicable legislation and regulations and they continually survey regulatory policies and practices to provide our clients with up-to-date information that reflects developments and changes. This combination of knowledge and experience aids our clients in developing effective and successful regulatory strategies.

Our qualified and experienced regulatory affairs personnel can assist your company within the following product areas:

• Human Drug Products
  
• Veterinary Drug Products
  
• Biologics and Biotechnology-Derived Products
  
• Cosmetics
  
• Natural Health Products
  
• Medical Devices

Our Regulatory offering includes:

• Planning of Pharmaceutical Affairs Strategy
  
• Assessment of existing regulatory strategies and timelines and provide recommendations for change
  
• Establishment Licences
  
• Product License Applications
  
• Drug Identification Number (DIN) Applications
  
• New Drug Submissions
  
• Abbreviated New Drug Submissions
  
• Supplemental submissions
  
• CTD preparation (including electronic file preparation eCTD)
  
• Natural Health Product License Application
  
• Drug Master File (DMF) Preparation and support for Registration
  
• Notifiable Change
  
• Support for communication with authorities from application to approval
  
• Due Diligence: Review of Regulatory Portfolio
  
• Scientific writing, including study reports