Regulatory Support

Regulatory Support 2013-02-04T10:54:21+00:00

Navigating a complex series of regulatory requirements is not a simple process.  Reducing development and regulatory adjustment time can maximize your product’s lifetime of marketability.

VxP Pharma can provide you with comprehensive regulatory documentation and support services. Our regulatory compliance team has the pharmaceutical experience and capabilities to write and compile comprehensive CMC regulatory packages for IND/CTA and NDA applications.  Our consultants can provide detailed, comprehensive product development and regulatory requirement services to achieve your specific needs.  We can offer the best solutions for product development that adhere to regulatory guidelines for all phases of development.

With VxP Pharma, you benefit directly from our extensive knowledge of the global CMC regulatory setting, and our expertise in directly engaging with multiple regulatory agencies.  Our team has developed a strong working relationship with important domestic and international trade associations and with regulatory and scientific advisors within the Canadian, US, European and Australian regulatory communities.

From API, preformulation, formulation to documentation services, you can trust VxP Pharma’s expertise in providing you with a comprehensive and effective regulatory guidance and services.

Some of our regulatory services:

  • Preparation of CMC documentation for regulatory compilation and submission
    • Global marketing applications (e-CTD)
    • Investigational Medicinal Product Dossiers (IMPD)
    • Investigational New Drug Applications (IND)
    • Quality Overall Summaries (QOS)
    • Clinical Investigator Reports (CIB)
    • Integrated drug development reports
    • Release testing/Monographs for API and other drug products
  • Review of technical CMC documentation prepared in-house
  • Consultation and response preparation to questions from agencies
    • Responding to regulatory CMC questions
    • Preparation of position papers and specific responses for potential regulatory questions

Our state-of-the-art labs are staffed by some of the best trained and most experienced subject matter experts in the field.

Contact us today for a free consultation with our scientific team and discover how VxP can be a valuable resource and partner for your organization.