CLIENTS & CASE HISTORIES
CMC Regulatory Services’ clients include some of the most innovative and successful biopharmaceutical companies in the world. They range from small emerging startups through growing mid-size companies to major multinational biopharmaceutical corporations.
Our decades of experience helping all sizes of companies solve regulatory challenges, and put those solutions to work in writing regulatory submissions and achieve market approval have kept us flexible and nimble. We stand ready to adapt to the unique needs of each of our clients, and we are proud to help deliver the next generation of medicines to the patients who need them.
Among the many companies we have helped, some of our clients include:
CASE HISTORIES
CMC Regulatory Services, LLC has helped dozens of biopharmaceutical companies solve regulatory challenges and produce successful regulatory submissions. We find compliance solutions that clear regulatory road blocks. Here are a few recent examples of how CMC Regulatory Services created stronger CMC submissions that helped clients reach their goals more efficiently:
“Demonstrating comparability across complex analytical methods for cutting-edge biologics”
CMC Regulatory Services was brought on to help a pioneering biopharmaceutical company that needed expert help to write the BLA for one of the first CAR T-cell therapies. We worked closely with a team of SMEs to establish the final CQAs and CPPs for the manufacturing process and author the crucial Pharmaceutical Development section. In addition, we produced a working protocol for standardizing analytical method development, allowing the client to demonstrate continuity of CQA measurement between early phase and late phase trials.
“Accelerating submission development with targeted regulatory strategy and de novo authorship”
A small virtual company was seeking 505(b)(2) approval of a combination product using a new formulation for an established generic a novel delivery system. This product was originally approved in Spain. Unfortunately, what the client assumed would amount to a relatively quick technology transfer from Europe had slowed to a crawl.
To get the IND back on track, CMC Regulatory Services conducted a thorough gap analysis, identified substantial development work that could be shifted from the IND to the NDA. This paved a focused path to a successful IND, which we helped deliver on a tight timetable by authoring Module 3.
“Overcoming unanticipated regulatory obstacles with innovative solutions and direct support”
A growing biopharmaceutical company had achieved breakthrough therapy approval for a novel mAb targeting a severe ocular disorder and faced market pressure to quickly expand commercial production. Unfortunately, FDA responded negatively to their proposed post-approval process validation for scaling-up their manufacturing. CMC Regulatory Services was brought in to provide crucial regulatory advice and manage the cross-functional team to generate a prior approval supplement that efficiently solved the company’s scale-up challenges.
“Accurately weighing risk to provide effective solutions to unique challenges”
A biologics company focusing on cutting-edge regenerative therapies had taken on the major challenge of adapting a novel European combination product (an autologous cell therapy delivered via an implant device) to meet FDA regulations. Showing that the US version of the combination product was comparable to the version approved in the EU was critical to convincing FDA regulators to accept a BLA with data from only one US clinical trial.
By focusing on CQAs crucial to performance and safety, we recommended a course of action and helped develop a protocol that was used successfully to demonstrate comparability between the client’s product and the original European product.