Drug Biologics License Applications (BLAs)

Protheragen-ING Lab provides comprehensive drug biologics license application (BLA) services, specializing in guiding pharmaceutical and biotech companies through the complex BLA process. Our experienced team of professionals is committed to ensuring that your biologics meet all regulatory requirements and are approved promptly.

Overview

Navigating the regulatory landscape for biological drugs requires a deep understanding of the Biologics License Application (BLA) process. A BLA is a request for permission to introduce or deliver for introduction, a biologic product into interstate commerce in the United States. The application is reviewed by the Food and Drug Administration (FDA), which ensures that the biological product meets the necessary standards for safety, purity, and potency.

The BLA must contain information in certain categories, including:

a. Descriptive information about the manufacturing process.

b. Qualitative and quantitative information about the composition of the product.

c. Data from preclinical studies and clinical trials to demonstrate the product's safety, purity, and potency.

d. Samples of the product and summaries of results from testing to ensure consistency and stability of the product.

Our comprehensive support services

Regulatory Strategy and Consulting	BLA Preparation and Submission
Comprehensive regulatory strategy development. Customized consulting services to address specific regulatory challenges. Risk assessment and mitigation planning.	Detailed guidance on the preparation of the BLA, including the necessary forms, documents, and electronic submissions. Assistance with the compilation of preclinical, clinical, and manufacturing data. Ensuring that all sections of the BLA are complete and meet FDA requirements.
Clinical Trial Support	CMC (Chemistry, Manufacturing, and Controls) Services
Design and implementation of clinical trials that meet regulatory standards. Data management and statistical analysis. Preparation of clinical study reports and other necessary documentation.	Development and review of CMC documentation. Assistance with manufacturing process validation. Quality control and assurance services to ensure product consistency and compliance.
Regulatory Submission Management	Post-Approval Support
Project management services to oversee the entire submission process. Coordination with FDA on behalf of the client. Responses to FDA inquiries and assistance with advisory committee meetings.	Ongoing regulatory support after product approval. Assistance with post-marketing commitments and surveillance. Labeling and promotional review to ensure continued compliance.

Why choose us?

Our team comprises industry veterans with extensive experience in regulatory affairs and biologics development.
We are committed to the highest standards of quality in all our services, ensuring that your BLA submission is thorough and accurate.
We understand the importance of time in the drug approval process and work diligently to meet deadlines and expedite the approval We provide customized solutions tailored to the unique needs of each client and their specific biologic product.

If you are ready to begin the BLA process or need expert guidance on your existing application, contact us today to schedule a consultation. We look forward to partnering with you to bring your biologic innovations to market.

Services