Regulatory Affairs Services: An Overview

Developing and implementing a strategy to navigate FDA as well as the market landscape can be a challenging task for any pharmaceutical, biologic, or device company. Understanding the various regulatory requirements and pathways can be a time-consuming task and costly without proper guidance. As the regulatory and market situations are in a never-ending dynamic state, it is often necessary and more cost-effective to partner with an out-of-house regulatory and scientific consulting firm with broad and successful product development and regulatory experience.

Regulatory Affairs is the term describing the science and activities performed within industries such as healthcare, pharmaceutical, and device, that assure compliance with established regulations and practices.   Independent scientific and regulatory consultants are often contracted by domestic and international companies within these industries to ensure that their products are placed into the marketplace while abiding by current submission and practice standards that allow for safe and effective use by healthcare providers, patients, and consumers.  The success of any regulatory strategy is heavily dependent on the understanding of current applications of rules, regulations, and the ability to work and negotiate with government agencies (e.g. FDA).  Regulatory compliance is key during the entire life-cycle of drugs, biologics, and devices.   

PMA (Premarket Approval), 510(k) (Premarket Notification), BLA (Biologics License Application), IND (Investigational New Drug), ANDA (Abbreviated New Drug Application), and NDA (New Drug Application) regulatory services provided by regulatory consultants cover a variety of critical steps involved in the development and submission processes.  Not only crucial in the development stages, regulatory affairs expertise is important throughout the drug, biologic, and device life cycles.  This includes post-approval Phase IV safety and effectiveness regulatory affairs activities.  Upon approval or clearance, FDA often requires post-marketing studies and activities in addition to the typical standards and reporting required by regulations. These activities often require interaction with FDA and other regulatory agencies. Proper and effective management and conduct of these interactions is imperative for the successful development and marketing of products.  Any improper (even unknowingly) procedures, submissions, or follow-up may result in warnings or even marketing suspension/discontinuation. This usually occurs at an incredible expense.  Therefore, familiarity across product classes and experience with various regulatory processes and interactions is vital.  The U.S. government and FDA do provide regulations, guidance, and review.  However, it is the responsibility of the company/sponsor who owns the marketed product to ensure the product’s safety and effectiveness. Responsible companies continuously monitor and assess their products and are vigilant in regard to providing safe products to patients and consumers.  Therefore, it is extremely important to partner with a regulatory consultant who is experienced with market and Pharmacovigilance/safety activities, along with the proper regulatory submission practices.  This consultant must also be prepared to interact with FDA, as needed.

In essence, an experienced and efficient regulatory consultant can be viewed as the glue that binds various aspects of a regulated product’s successful development and continued successful marketing programs. The proper and quick responses and the solutions provided by scientific and regulatory consultants, such as BRG, are an important asset to any successful FDA regulated product’s life-cycle.   

Contact BRG with any PMA, 510(k), BLA, ANDA or NDA regulatory services needed to advance your program goals.