Biologics License Approval (BLA) & Submissions

In order to make sure you get it right the first time, ProPharma will combine our knowledge and more than 30 years of experience to plan and coordinate every detail of a clear and complete FDA submission. Many elements go into the submission, and any inaccuracies in administrative or technical information can lead to delays and issues during the review stage of the regulatory submission process. To ensure no such issues occur, our experts can help with the preparation of your FDA regulatory submission.

FDA Regulatory Submission Services

ProPharma offers expert guidance and regulatory submission support throughout the entire submission process. We’ll utilize our extensive experience and strong relationship with the FDA to ensure a seamless submission process. We provide consulting services for key FDA regulatory submissions.

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Biologics License Application (BLA)

A BLA is generally submitted after an Investigational New Drug (IND) or an Investigational Device Exemption (IDE) and after the appropriate studies have been conducted. A biologics license application applies to vaccines and other allergenic drug products, blood products, and cellular and genetic therapies. Planning and executing this process is an extremely involved and complex initiative requiring coordination, diligence, and domain expertise in several areas. We've helped many companies—big and small—plan and navigate the BLA process successfully, on time and on budget.

Get Expert Guidance From an BLA Consultant for Your Upcoming Submission