Regulatory Affairs

Regulatory Affairs

Taking new products successfully through development, submission and approval can be a difficult, expensive and lengthy process. PHACT’s regulatory affairs team is here to provide the experience necessary to deliver on aggressive timelines and control costs, while ensuring compliance and patient safety.

Whether your new product is a drug, a biologic, a vaccine, a diagnostic or even a combination, we have the resources and proven expertise to develop an appropriate development strategy. We can help guide you throughout all phases of development through to marketing approval.
We support you with the following Regulatory Affairs services

  • Regulatory strategy development
  • Representation with regulatory authorities
  • Preparation for and management of regulatory meetings
  • Preparation of Regulatory Submissions