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Additional Areas of Expertise

Regulatory Affairs

Regulatory Strategy and Feasibility

With our in-depth knowledge of global Early Access (US; Expanded Access) regulations and close to 25 years of in-house EAP regulatory experience, we have the ability to advise and collaboratively develop strategies to support each client’s specific development needs. For a decade we have designed, implemented and executed global programs. Our experience encompasses Expanded Access Programs for orphan (ultrarare) diseases, compounds for urgent treatment, as well as larger scale group programs pre- or post-marketing authorization.

 

Our process begins with rigorous analysis to understand the research and treatment objectives and needs of the client’s specific program(s). We then build out a regulatory strategy that meets the program’s goals. We share our strategy and feasibility expertise by building and running entire programs or by providing project-based consulting.

Regulatory EAP Program Support

We strive to be a full-service partner with a comprehensive, transparent and goal-driven offering. Our services include regulatory and operational guidance, drafting program documentation, executing regulatory authority submissions and supporting physicians in providing the necessary informational documents. We proactively engage with regulatory authorities and provide accurate and timely communication related to the EAP (e.g. submission, dossier maintenance and reporting). Our expertise includes regulatory and medical writing to support complex regulatory and access submissions. For each and every client, we build a strong partnership, providing a turnkey solution and comprehensive services.

 

Compliant distribution of a client’s investigational drug is our priority. Our regulatory protocols, logistics processes and order system allow for traceability and assure local compliance. Every shipment is linked to a regulatory dossier wherein the necessary approval is kept and validity (including a verification of the prescribing physician) is confirmed. We believe such rigor is critical in a rapidly growing, ever-changing global market.

 

We are experts in navigating the complex world of Expanded Access and in the implementation of global programs. Having captured extensive global regulatory intelligence, our team has a continuous focus on understanding pre-approval access laws and regulations for each country — including pharmacovigilance and labeling requirements. We have mapped out access pathways around the world, as well as identified opportunities in each country to collect valuable treatment data outside of clinical trials.