• Comprehensive support for regulatory submissions and interactions related to Chemistry, Manufacturing, and Controls (CMC) for pharmaceuticals and biologics.

  • Tailored support for all stages of product development, from early research to post-approval changes.

  • Expertise in developing and submitting regulatory documents, such as Investigational New Drug (IND) applications, New Drug Applications (NDA), and Biological License Applications (BLA).

  • Skilled in preparing responses to regulatory agencies' questions and requests for additional information.

  • Support for CMC-related regulatory interactions, including meetings with regulatory agencies, teleconferences, and correspondence.

  • Assistance with CMC-related regulatory strategies, including preparation for and participation in Health Authority meetings.

  • Proactive monitoring of regulatory changes and guidance, ensuring clients stay up-to-date with the latest requirements.

  • Strong commitment to quality, accuracy, and timely delivery of services.