The Biologics Consulting difference is the unique combination of expertise we have under one roof – from pre-IND and IND consultants to clinical trials and product development consultants. Our team brings a depth of knowledge and breadth of experience across product types and development pathways, allowing us to address the full scope of a client's regulatory and product development needs. Our experts possess unmatched insight and experience in both the regulatory and product development processes. Many have held positions within the FDA and/or were senior leaders with industry experience, and during their careers have played instrumental roles in crafting the policies and procedures used today. All are hands-on professionals with an intimate knowledge of the scientific, regulatory and business challenges that must be overcome in order to bring a new product to market.
We view each challenge as an opportunity to leverage our Industry and Agency experience in order to facilitate a better outcome for our client. Regardless of the issue, odds are that we've seen it before, either as a senior biotechnology/medical technology scientist, an industry executive or an FDA official. This unmatched combination of experience and insight is why we are the go-to regulatory consulting firm for biotechnology, pharmaceutical and medical device companies of all sizes, whether they seek assistance designing and implementing a CBER, CDER or CDRH compliance program, preparing a 510(k), PMA or BLA/NDA for a new product or designing and managing a clinical trial.
When you work with Biologics Consulting, an experienced subject-matter expert is always just a phone call away. No firm can match Biologics Consulting's depth of knowledge, breadth of experience and track record of success across the pharmaceutical, biologics and medical device sectors.
With Biologics Consulting as your success partner, you can rest assured that an experienced team of subject-matter experts with an impressive record of accomplishment in both product development and regulatory affairs is fully committed to helping you navigate the maze that is today's new product development process.