Regulatory Strategy Development
BioPharma Global provides measured and effective regulatory consulting to assist you in all phases of drug development. Depending on your needs, we can craft an overall drug development strategy or assess the feasibility of your planned program in consideration of current FDA and/or EMA policies. See our Regulatory Affairs Submissions page for further details on these programs.
Our Strategy and Feasibility Reports are tailored to your project and can provide:
- Background information on FDA and/or EMA policies and benefits relating to your drug development strategy and timeline.
- Identify potential Orphan indication/indications.
- Prevalence calculation for the indication or any relevant subset to determine the eligibility for an Orphan Drug Designation (ODD) or Rare Pediatric Disease (RPD) Designation.
- Market analysis of relevant successful case studies.
- An analysis of the competitive landscape, including previous regulatory approvals and clinical trials.
- Expert recommendations for the best path forward for your product.
- A concise strategy outlining the probability of success, next steps, and personalized approaches for your regulatory needs.
Development for chemistry, manufacturing, and controls (CMC) requires highly experienced professionals, who understand the regulatory aspects of CMC as it applies to the client’s project needs and the overall picture to achieve a successfully marketed product. Our experts can conduct an in-depth review of your CMC package, including but not limited to the following items: manufacturing process and controls, specifications, product chain of development, and stability. Our team will ensure your CMC development plan is proceeding in consideration of your overall drug development timeline and to meet the criteria required for FDA or EMA drug approval (or for the requirements of the target country for your approval).
With years of experience in the regulatory space, our experts can help prepare you for your meetings with the FDA and/or EMA. Collaborating with your team, we can craft the meeting questions, draft the meeting request and briefing package, prepare your team for the interaction, and represent your company to the regulators. After the meeting, we debrief you, write the meeting minutes, and plan next steps based on guidance from the regulators. Together we can ensure your meeting with the FDA or EMA is productive, leading to a clear pathway for development of your drug.
During early stages of development, some companies need help determining whether their product qualifies for orphan drug designation or any of the expedited approval programs offered by the FDA and EMA. We conduct feasibility assessments to determine the likelihood of your product successfully receiving these incentives.
Designing clinical trials and determining endpoints relies heavily on the regulatory requirements for your product’s application. BioPharma Global can review your current pool of data and help determine the best endpoints needed to demonstrate efficacy, safety, or any other relevant endpoints needed in your application(s). We will review your report detailing the optimal design for your P1, P2, P3, and/or pediatric studies.
BioPharma Global is ready to work with your team on the best possible regulatory strategy for drug development in the US and/or EU. Drawing on our highly experienced staff and review of your existing data and overall development goals, we can produce a strategy detailing preclinical studies needed prior to IND or CTA submission, timelines to approach FDA or EMA, clinical trial design, endpoint considerations, and an approach to obtain orphan/expedited program(s) exclusivity.
Once you are ready for submission to the FDA and/or EMA, we can provide commentary on the regulatory risks likely to be incurred with submission and an approach to mitigating these risks.