April 11, 2016

Regulatory Affairs

Regulatory Affairs broadly describes the activities surrounding interactions with the FDA and other governmental regulatory bodies throughout the world during the drug/biologic/device development process. Current regulatory expectations are scattered through myriad statutory and guidance documents put out by FDA, other international regulatory agencies, and the International Conference on Harmonization (ICH). It is no simple feat for seasoned and novice drug developers alike to keep abreast of all of the regulatory requirements that will impact their own development activities.

PharmaDirections brings its breadth and depth of Regulatory Affairs experience to the table not only in preparing submission documents but also in guiding everyday strategic and operational decisions. This critical guidance can eliminate unnecessary delays in development that can spell the difference between success and failure in the face of time and resource limitations. PharmaDirections completes several regulatory filings each year on behalf of its clients.

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  • From beginning to end, PharmaDirections can actively support your needs in this critical area. We offer individual experts or a team who can individually or collectively support the following:
  • Pre-Submission Meetings (for devices and combination products)
  • Request for Designation submissions (for combination products): A submission to formally request assignment of the appropriate review division at FDA.
  • Author all sections of IND Submissions, and support the submission process
  • Author IMPDs and CTA for submission to European regulators
  • Preparation for, and attendance at, Type A, B and C meetings with FDA, and the equivalent meetings in European countries
  • Author CMC sections of documents required for an NDA or BLA
  • Pre-Approval Inspection support
  • Author IND annual reports and IND Amendments
  • Manage all interactions with regulatory agencies on behalf of the sponsor company