Regulatory Affairs Consulting
Biotech & Pharmaceutical
Regulatory Affairs Consulting
Our seasoned pharmaceutical physicians and functional specialists work to ensure that your program is on the optimal path forward, balancing risk and value, while responding to changes in the external environment. Cytopharma’s core team leverages 150+ industry-experienced, clinical development strategy and operations consultants, with backgrounds spanning a broad range of therapeutic areas and product modalities. Our extensive consulting resources allow us to offer you versatile, fit-for-purpose expertise that can be tailored to the exact needs of your clinical development program, enabling us to support you in each crucial area from planning and strategy to execution and tactical support.
Each member of our team brings significant industry experience from a career either working within regulatory agencies or with shepherding pharmaceutical and biotech products through regulatory processes. We have extensive expertise with both FDA and EMA regulations and many years of experience interacting with those regulatory bodies.
Our group has deep preclinical, CMC and clinical regulatory experience covering a broad range of therapeutics including small molecules, biologics, and ATMPs such as cell and gene therapies. By combining our core team with the extensive capabilities of our specialized consulting network, we’re able to provide regulatory support that is precisely tailored to the exact regulatory needs of your project, throughout the product development cycle.
Regulatory consulting services we provide:
More specifically, a regulatory feasibility study assesses your regulatory strategy and plans, including proposed timelines and costs, to ensure they are accurate and on target. Our assessments help clients ensure regulatory expectations are not only reasonably set and achievable, but that the chosen path is the most efficient one leading to the fastest approval.
As part of this, our regulatory affairs consultants also recommend the best path forward to approval, including any expedited pathways such as Fast Track or PRIME that your program may qualify for. Our expertise covers both the FDA and the EMA, and we have consultants who specialize in a range of technologies and therapeutic areas.
We perform regulatory due diligence both for internal purposes as well as for outside parties engaged in licensing, investment or M&A activities. The objective is to uncover any red flags that may affect the general success of the regulatory strategy and consequently, current clinical and commercial plans.
Our regulatory team can help you prepare for an upcoming IND submission, including both strategic and hands-on support for initial meetings with the FDA or EMA. Within our Expert Network, we have consultants who specialize in each critical aspect of IND-readiness, including toxicologists and pharmacologists, who can review preclinical studies to ensure they will meet FDA/EMA expectations.
We also advise clients on the meetings themselves, including with crucial items such as how to best structure questions. In addition, we can attend meetings with you, as well.
We can advise you strategically on how best to approach applying for an expedited program or an orphan drug designation. We are also able to provide hands-on support with the application process itself, including with appealing decisions.
We can provide hands-on support for CTA and IND submissions, ranging from high-level guidance and review to our team fully preparing and managing the submission, including writing and publishing eCTD-compliant IND package documents.
Contact us
Discuss our consulting services for the pharma & biotech industries with us.