To gain regulatory approval, you need the right navigator.
We are your regulatory support team.
We have decades of collective experience working with the FDA and maintain active working and consultative relationships with ex-FDA staff members. This makes it easier to navigate the department and helps eliminate potential regulatory hurdles before they happen, giving your drug the best possible chance of getting across the finish line.
Today’s State of Affairs
Current regulatory expectations are scattered through myriad statutory and guidance documents put out by the FDA, other international regulatory agencies, and the International Conference on Harmonization (ICH).
At PharmaDirections, we bring our deep and broad Regulatory Affairs experience to the table not only in preparing submission documents but also in guiding everyday strategic and operational decisions. This helps eliminate unnecessary delays in development that can spell the difference between success and failure.
This paradigm is standard throughout the industry as it leverages the best assets of each resource in a cost-efficient manner.
Each year, we complete several regulatory filings on behalf of our clients:
Type of Filing
- CNS Disorders
- Endocrine Disorders
- Cystic Fibrosis
- Small molecules
- Inhaled / Nasal
- Topical / Transdermal
Why Partner with Us?
From beginning to end, we offer individual experts or a team who can individually or collectively support your regulatory needs:
- Pre-Submission Meetings (for devices and combination products)
- Request for Designation submissions (for combination products)
- Authorship of all sections of IND Submissions and support the submission process
- Authorship of 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
- Authorship of CMC sections of documents required for an NDA or BLA
- Pre-Approval Inspection support
- Authorship of IND annual reports and IND Amendments
- Management of all interactions with regulatory agencies on behalf of the sponsor company