The development and marketing of biologics and vaccines in the U.S. are tightly regulated by the FDA to ensure safety, efficacy, and quality. Compliance with regulatory requirements, including Biologics License Applications (BLA), Investigational New Drug (IND) submissions, and GMP standards, is essential for legal distribution and clinical trial approval.

At XPRO AMERICA, we provide end-to-end regulatory support for biologics and vaccine manufacturers, helping navigate complex FDA requirements and accelerating product development and approval timelines.

Key Services:

• Biologics License Application (BLA) Support: Preparing and submitting BLA applications for FDA review, including detailed clinical, nonclinical, and CMC (Chemistry, Manufacturing, and Controls) documentation. XPRO AMERICA ensures submissions are complete, accurate, and formatted to FDA standards.
• IND Submissions for Biologics Trials: Investigational New Drug applications are required to initiate clinical trials. We assist with IND preparation, protocol development, and FDA communication to secure trial approvals efficiently.
• Cell & Gene Therapy Regulatory Support: Advanced therapies such as cell and gene therapies require specialized regulatory guidance. XPRO AMERICA advises on preclinical studies, clinical protocols, and FDA submission pathways, ensuring compliance with emerging regulatory requirements.
• GMP Compliance for Biologics Facilities: Facilities producing biologics and vaccines must adhere to Good Manufacturing Practices (GMP). We provide audits, gap analysis, and corrective action planning to ensure operational and documentation compliance.
• Regulatory Strategy & Ongoing Support: From preclinical development to post-market surveillance, we guide clients on FDA interactions, submission strategies, and compliance with evolving biologics regulations.

Why Choose XPRO AMERICA?

• Deep expertise in biologics, vaccines, and advanced therapy regulatory requirements.
• Comprehensive support from IND through BLA submission and GMP compliance.
• Proven track record in FDA communications, clinical trial approvals, and regulatory strategy.
• Minimizes risk and accelerates time-to-market for biologics and vaccines.

Partnering with XPRO AMERICA ensures that biologics and vaccine developers navigate FDA regulatory pathways efficiently, maintain GMP compliance, and achieve successful approvals while safeguarding patient safety. Our services streamline submissions, mitigate risk, and provide strategic guidance for all stages of product development.

XPRO AMERICA supports biologics and vaccine developers with BLA, IND submissions, GMP compliance, and cell & gene therapy regulatory guidance.