BLA Regulatory
BLA Regulatory, LLC is a full-service biopharma regulatory consultancy with extensive experience in drug development, regulatory strategy, and global market engagement. They support clients through all phases of product development, from pre-IND planning to post-marketing activities, across major markets including the US, Europe, Australia, China, and Japan. Their team has a combined experience of over 130 years, with a broad expertise in therapeutic areas such as oncology, respiratory, autoimmune, and cardiovascular diseases. They have a proven track record with over 300 INDs and 50 NDAs/BLAs, providing services in regulatory, CMC, nonclinical, clinical, biostatistics, scientific writing, project management, eCTD publishing, and submission.
Industries
Nr. of Employees
small (1-50)
BLA Regulatory
610 Professional Dr. Suite 225, Gaithersburg, MD 20879
Services
Assessment to identify regulatory gaps and risks and to recommend corrective actions and strategy.
Preparation and representation for formal interactions with regulatory agencies, including briefing document development.
End-to-end support for IND preparation, eCTD assembly, electronic submission, and post-submission maintenance.
Identification and recruitment of principal investigators for clinical trials.
Acting as U.S. agent for non-U.S. sponsors to fulfill regulatory communication and representation obligations.
Registration of clinical studies and support for related regulatory requirements.
Assessment to identify regulatory gaps and risks and to recommend corrective actions and strategy.
Preparation and representation for formal interactions with regulatory agencies, including briefing document development.
End-to-end support for IND preparation, eCTD assembly, electronic submission, and post-submission maintenance.
Identification and recruitment of principal investigators for clinical trials.
Acting as U.S. agent for non-U.S. sponsors to fulfill regulatory communication and representation obligations.
Registration of clinical studies and support for related regulatory requirements.
Expertise Areas
- Regulatory strategy and submissions (IND/BLA/NDA)
- Clinical development and early-phase trials
- CMC and manufacturing for biologics and advanced therapies
- Nonclinical and toxicology study design
Key Technologies
- eCTD electronic dossier publishing
- VLP-based delivery for in vivo gene editing
- CRISPR in vivo gene editing
- Cell therapy (CAR-T, allogeneic NK cells) development
News & Updates
BLA Regulatory was Awarded as One of the Top 10 Emerging Consulting Companies of 2022
BLA Consulting will attend the BIO International Convention 2025 in Boston, MA from June 16-19, 2025, representing their expertise in regulatory strategy, clinical development, and global agency engagement.
BLA Regulatory congratulates Gluetacs Therapeutics on receiving the IND may proceed letter from the FDA for the GT919 project, an IKZF1/3 Targeted Immunomodulatory Drug Candidate for relapsed or refractory Multiple Myeloma.
BLA Regulatory congratulates Leads Biolabs on receiving the IND may proceed letter from the FDA for LBL-033, an anti-MUC16/CD13 bispecific antibody for ovarian cancer and other malignant tumors.
BLA Regulatory congratulates ImmuneOnco on receiving the IND may proceed letter from the FDA for IMM2520, a CD47×PD-L1 bispecific molecule for solid tumors.
BLA Regulatory congratulates Hangzhou Hanx Biopharmaceuticals on receiving the IND may proceed letter from the FDA for HX009, a bispecific PD-1/CD47 antibody for lymphoma.
BLA Regulatory was Awarded as One of the Top 10 Emerging Consulting Companies of 2022
BLA Consulting will attend the BIO International Convention 2025 in Boston, MA from June 16-19, 2025, representing their expertise in regulatory strategy, clinical development, and global agency engagement.
BLA Regulatory congratulates Gluetacs Therapeutics on receiving the IND may proceed letter from the FDA for the GT919 project, an IKZF1/3 Targeted Immunomodulatory Drug Candidate for relapsed or refractory Multiple Myeloma.
BLA Regulatory congratulates Leads Biolabs on receiving the IND may proceed letter from the FDA for LBL-033, an anti-MUC16/CD13 bispecific antibody for ovarian cancer and other malignant tumors.
BLA Regulatory congratulates ImmuneOnco on receiving the IND may proceed letter from the FDA for IMM2520, a CD47×PD-L1 bispecific molecule for solid tumors.
BLA Regulatory congratulates Hangzhou Hanx Biopharmaceuticals on receiving the IND may proceed letter from the FDA for HX009, a bispecific PD-1/CD47 antibody for lymphoma.