Led by individuals with more than 20 years in the industry, our Regulatory Affairs team has broad experience in pre and post-market drug and biologic regulation. We provide comprehensive global support to Sponsors across all stages of the product development lifecycle, from pre-IND/IMPD submission through marketing application and regulatory review.
Our highly qualified Regulatory consultants, Clinical staff, Data Managers, Statisticians and Medical Writers work in concert with our Sponsors to ensure the clinical, scientific and regulatory integrity of every project. We keep pace with the ever-evolving regulatory requirements by region and are experienced in clinical trial submissions to IRBs/ECs, the FDA and ex-US Competent Authorities.
- Strategic guidance on the clinical development plan of a new product and label expansion of existing products.
- Compilation and submission of Briefing Packages.
- Formulation of pre-IND and pre-NDA questions to the FDA.
- Correspondence with the FDA on pre and post-meeting logistics and actions.
- Participation in FDA meetings.
- Preparation of the IND.
- Authoring of clinical components (e.g., Investigators Brochure and Protocol)
- Preparation and coordination of responses to FDA Requests for Information.
- Project management and strategic guidance over the life of the IND.
- FDA, ex-US Competent Authority and MoH submissions.
- Compilation and submission of Protocols, CMC Updates, Nonclinical Study Reports, and Clinical Study Reports.
- Preparation and submission of 7-Day and 15-Day Safety Reports.
- Preparation and submission of Annual Reports.
- Preparation of the NDA.