BLA Preparation Services

Regulatory submissions are complex and critical to a drug development program; content requirements for CTD format and the timing can be critical. Negotiating what you need to file and when with the FDA can be a delicate dance. CMC Compliance Services offers a wide variety of BLA Preparation services, including:

• Regulatory Submissions (See Details)

  • BLA, NDA, MAA, IND, CTA, DMF

    • All submissions done in Modules 3 and 2.3 CTD format

    • Filing strategy

  • Pre-meeting packages (all meeting types)

  • Responses to Requests for Information

• Agency Interactions (See Details)

  • Serve as primary contact person with FDA

  • Represent clients at meetings with FDA

QA/Compliance

Nothing is more important to patients across the globe than the quality of their biopharmaceutical treatments. This must be based on a fundamental trust between patients and biopharmaceutical manufacturers. We give you the tools and support to fulfill your commitment to the people who count on you everyday by providing Quality Assurance and compliance services, including:

• Due diligence for M&A and investors (See Details)

• “For cause” and remediation audits (See Details)

• Compliance gap analyses (overall system assessment) (See Details)

• QMS assessment (Quality System focus) (See Details)

• De novo Quality Management Systems for startups (See Details)

• Responses to 483s, Warning Letters and Untitled Letters

GMP Training

Understanding the regulations that govern the development, manufacture, and marketing of biopharmaceuticals is critically important for every member of every team involved in their process. Our GMP training offerings include:

• Basic and Refresher Courses for Employees (See Details)

• GMP Training for Executive Management (See Details)

Tailored GMP training courses can also be developed for your specific needs, such as your new marketing department. or your investors.