The research and development process of bringing a new drug to the market can take many years; it is therefore essential that the process is managed effectively from beginning to end to meet the regulatory requirements and permit a favorable evaluation of efficacy and safety in the shortest possible time. This is where we come in – BLA Regulatory will play an important role in every phase of this process, from developing regulatory strategies following the discovery of an innovative or biosimilar drug product to planning post-marketing activities.
With a combined experience of more than 130 years, our team brings in collective knowledge from major biopharmaceutical companies, CROs and the U.S. Food and Drug Administration (FDA). They have real and extensive experience in the complete drug development cycle with records of approvals for innovative drugs crossing therapeutic areas such as oncology, respiratory, autoimmune, inflammatory, metabolic and cardiovascular diseases. Our FDA veterans can also provide strategic expertise for therapeutic proteins, gene and cellular therapies including monoclonal antibodies, biosimilars or innovative antibodies, Fc-fusions, enzyme replacement therapy products, cytokines, hormones, CAR-T, and gene therapy. Also, BLA Regulatory has expertise from industry and FDA advising the development of small molecule drugs for 505(b)(1) and 505(b)(2) regulatory pathways.
As your partner and extension of your team, we will leverage our strengths to ensure:
Oversight of Full Product Life Cycle
BLA Regulatory can help you navigate the complex regulatory landscape throughout the product development cycle. The scope of our services ranges from the start of product research, nonclinical and clinical development, right up to the post-marketing stage of the process, including the plans to test the product before it’s ready for marketing. BLA Regulatory also arranges consultations and meetings between our client company and government regulatory agencies, including the compilation of briefing documents. The team will also manage communication between the external regulatory agencies and you, the sponsor.
Compliance of the Product Development Program
The BLA Regulatory team will work with our clients to develop the regulatory strategy and integrate legal constraints into product development plans. At this stage of the product life cycle, our CMC, nonclinical, statistics and clinical experts will work to identify and mitigate regulatory gaps and compliance issues. Our approach emphasizes building up marketing applications from a solid IND strategy by providing expertise, regulatory intelligence and translating regulatory requirements into practical workable plans throughout the development phase.
Compliance of the Product Marketing Campaign
Before the product is marketed, the Sponsor has to submit a marketing application to the public regulatory agency. To avoid failure or costly delays at any point in this process, BLA Regulatory will provide the strategic regulatory framework for submissions of New Drug Applications or Biologic License Applications to the U.S. FDA. Balanced with this duty of compliance, BLA Regulatory strives to be efficient and minimize the lead time in bringing your company’s product to market. During the marketing application review, BLA Regulatory will also manage and represent your company in pre-BLA, mid- and late-cycle review meetings, and in pre-approval advisory committee meetings. Once the product obtains marketing authorization, we will support our client with product life-cycle management.