Issue 4 2022

ProPharma Group: Best Pharmaceutical Regulatory & Compliance Consultancy 2022 Science Minds over Regulatory Matters - Helping Emerging BioPharma & Device Companies Meet Their Objectives We provide support for a wide range of products including large or small molecules, medical devices and diagnostics, combination products, vaccines, generics, dietary supplements, IVD, nicotine replacement, and cell and gene therapy (ATMP). You name it and we have probably worked on it. C-Suite executives from emerging biotech and device companies choose ProPharma Group Regulatory Sciences (PPG-RS) for support because their success depends on optimal interactions with and submissions to regulatory agencies worldwide. For most clients, their first interaction with FDA is a Pre-IND Meeting; this critical meeting sets the tone for the entire development path. The difference between a great Pre-IND Meeting and a mediocre meeting is measured in years of development time and millions of dollars. ProPharma Group’s Vice President, Business Development, Jeff Antos says “this is one example of why it is so important to choose the most qualified consulting group to assist with the regulatory process”. In selecting a consulting group, the most important characteristics are as follows: • Scientific Credentials and Expertise: PPG-RS consultants have M.D.s, Ph.D.’s and other advanced degrees in key scientific disciplines representing toxicology, nonclinical, medical, clinical, drug safety, CMC, clinical pharmacology, biopharmaceutics, and medical device. • Frequent Interactions with Regulatory Agencies: Frequent interaction is necessary to understand key issues, personalities, and other nuances of Agency reviewers in each of the review divisions. PPG-RS has several meetings with review divisions each month. Our US office is in Washington, DC, enabling clients to conveniently prepare for and debrief from FDA meetings. • Experience: In his book, “Outliers,” author Malcom Gladwell states that, “it takes 10,000 hours of intensive practice to achieve mastery of complex skills and materials.” Each of our many strategists has more than 50,000 hours providing regulatory support. Unlike many of our competitors, PPGRS does not have a “B-Team.” The individuals you meet at the outset of the project are the people you will be working with for its duration. • Track Record of Success: Over the past four decades we have conducted approximately 30 successful formal meetings with FDA and EMA each year, including Pre-IND, End of Phase 2 Pre-NDA, Type C, INTERACT, Pre-Submission and Scientific Advice. During that same time period, we have submitted hundreds of successful INDs, NDAs, BLAs, ODDs, MAAs, 510(k)s, DeNovos, PMAs IDEs and Request for Designations. • Honest and Direct Advice: Our gap analyses and strategic assessments sometimes result in advice that the client would rather not hear. For example, on some occasions, when a client has wanted to request a Pre-IND meeting immediately, we have advised them that they will have a better outcome if they accomplish some of the prerequisites (e.g., a specific nonclinical study) first. • “Glocal” Reach: Local presence is necessary for regulatory success. We have a global footprint of local presence for FDA (US), EMA (Europe), MHRA (UK), PMDA (Japan), NMPA (China), TGA (Australia) plus many other countries. • Wide Range of Services: In addition to Regulatory Sciences, we offer our clients a comprehensive suite of services throughout the full product lifecycle available globally, including quality/ compliance services, R&D technology, clinical research solutions, medical information/pharmacovigilance, and post approval commercial support. • Flexibility: Every client has unique goals, objectives, styles of working and personality. We adapt our style to mesh with client teams, thereby becoming a single team dedicated to accomplishing milestones and business objectives. • Project Management: Effective project management is essential to project success. All of our projects have assigned PMs who are responsible for delivering contracted project results on time and within budget, managing the PPG team and communicating with the client team. How we work We can start anywhere in the process. Some clients come to us at the end of the process, requesting a review of their documentation prior to submission or for electronic publishing assistance. Whereas a majority of clients come to us at the beginning of the process with three things: a product, an indication and a question. Their question is, “what is the best way to get our product approved,” where best means cheapest, fastest, and highest probability of success. So, we spend time with our clients developing what we sometimes call a “Roadmap to Approval,” considering not just regulatory but assessing all of the scientific disciplines necessary for success, including nonclinical, clinical, CMC and clinical pharmacology. “The reason why we exist is simple: we help our clients get their drug and device products approved.”