BLA Regulatory
Giving Pharmaceutical Companies the Regulatory Upper Hand

Having worked for one of the top ten pharmaceutical companies in the US for over 10 years, and having served a clinical-stage pharmaceutical company as the US Site Head and Senior Regulatory Lead, Frank Li witnessed the first-hand need that big pharma organizations, as well as small biotech start-ups, had for consultative guidance for developing products in ways that best aligned with pharma regulations. Kindling his entrepreneurial spirit, Li founded BLA Regulatory, LLC, in May 2019 to fulfill that largely unmet need.

BLA Regulatory has since supported various start-ups and clinical-stage companies with limited experience with US FDA regulations, to meet FDA’s requirements throughout the Nonclinical Research, Clinical Development (Phase 1, Phase 2, Phase 3), Marketing Application (NDA, BLA, ANDA), and the Post-Marketing phases. They have extensive experience in the preparation, authoring, and formulation of defense strategies for any consulations with the FDA (Pre-IND, EOP, Pre-NDA/BLA).s The company addresses all regulatory concerns around CMC, non-clinical issues, clinical trial design, eCTD and medical/scientific writing, legacy toxicology study reports, GLP compliance, rare disease's historical data usage, immunogenicity high positive rate, and justification of primary endpoints changes.

With clients in the US, Europe, and Asian countries like China, Japan, and South Korea, BLA Regulatory helps its customers fulfill the regulatory requirements to ensure novel drugs reach the patients that need them worldwide. The company even organizes online seminars and courses in collaboration with popular regulatory advisors for its customers in Asian countries. Frank Li, Founder and CEO, commented “I saw the market need, and strived to share my regulatory knowledge with the companies in the US and Asia, based on my experience in the global regulatory landscape (US, EU, China, and Japan).

The added advantage of BLA Regulatory is the global cultural awareness and the fluency of some of our consultants in three languages - English, Chinese, and Japanese.”

The drivers of an IND drug (small molecule, large molecule, and gene & cellular products) are mostly scientists who develop the drug with support from other technical experts. However, at the drug candidate validation and/or preclinical stage, few companies have the resources to have an in-house regulatory team to support early drug development. Therefore, providing a tailored, start-to-end scope of regulatory consulting services can meet the needs and overcome the challenges companies face at early clinical development stages. To this end, BLA Regulatory can either work with the client together as a partner or provide them with all the services they may need as and when required.

The main driving force that aids BLA Regulatory in guiding its clients from the IND/CTA to NDA/ BLA regulations smoothly is its principal consulting partners from the biopharma industry and the FDA. With each partner having over 15 years of experience, the experts guide the customers about pharmaceutical regulations in many forms, whether as an evaluator/examiner from a regulator's perspective or as a highly experienced industry insider.

The organization further provides clients with two consultants if they want: one, an ex-FDA reviewer, and the second, a drug development industry veteran. The combined expertise enables the clients to address the drug development issues and mitigate the potential risks in a way that soothes the needs of both the regulators and the drug companies. Additionally, some of the consultants are capable project managers who worked in multi-national, multi-language backgrounds. They bring cultural awareness and project execution expertise that encompasses basic research through IND and marketing approvals.

As a nimble regulatory consulting service company, BLA Regulatory, in many ways, is an ideal fit, especially for smaller pharmaceutical start-ups and less experienced clinical-stage companies. The company pays undivided attention to its client's needs and provides reliable, fast, fully-attentive, and customized regulatory services. Their customers will never have to worry about any unforeseen complications and can potentially get IND/CTA clearance or NDA/BLA approvals for their drug smoothly and effectively.