Experienced Regulatory Consultants

All of our senior regulatory consultants have many years of frontline knowledge in drug development. They either worked in biopharma companies in development functions, or in regulatory agencies reviewing applications and setting up policies. Our team has broad experience covering traditional small molecule, biologics, and the cutting-edge gene and cell therapy.

One-stop Regulatory Services

BLA Regulatory thrives to provide end-to-end services for your IND, NDA and BLA needs. Our qualified expertise expands across CMC, preclinical, clinical, regulatory, biostatistics, as well as scientific writing and project management. Our records of approvals for innovative drugs span major therapeutic areas, including oncology, respiratory, neurology, autoimmune, inflammatory, metabolic, and cardiovascular diseases. BLA Regulatory can help you craft pre-IND strategies, communicate with regulatory agencies, as well as author and submit eCTD-compliant applications.

Major Markets Coverage

BLA Regulatory has working knowledge with major regulatory agencies, including FDA, EMA, TGA, PMDA and NMPA. In response to rapid evolution in drug development, the regulatory regimes are in constant development. Our consultants are in close contact with these changes to make sure the our applications in conformation to the latest requirements. BLA Regulatory has networks of local experts in handling regulatory and clinical needs. Some of our local affiliates provide their perspectives:

Australia has world class clinical research infrastructure and highly experienced investigators. In addition to the fast start-up and streamlined regulatory process, the government invested heavily in the clinical development capabilities, not the least of which is the research tax credits. “
– Ms. Li, Sydney, Australia, BLA’s

“Central and Eastern Europe has attracted big pharma and biotech alike with…“
– Indra, Latvia

“South America is key destination for clinical development ….”
– Buenos Aires

Efficient Project Management

BLA Regulatory follows a tried-and-true process for successful IND approval. Our senior regulatory consultants typically start working with a client at pre-IND stage. Through a Gap Analysis, we identify potential deficiencies in an application to avoid delays down the road. We then move in to the pre-IND meeting preparation. Based on the agency’s feedback, we will build the IND application. Throughout the process, BLA Regulatory has an assigned Project Manager to manage the timeline, budget, and communicate with you regularly.