Analytical Directions

Analytical Directions is a specialized consulting firm providing expert guidance in Chemistry, Manufacturing, and Controls (CMC) for the pharmaceutical and biotechnology sectors. The company focuses on analytical development, stability program design, and regulatory strategy to support drug development from early stages through commercialization. Their services include technical writing for regulatory submissions, laboratory audits, and troubleshooting complex analytical challenges. Led by industry veteran Gregory P. Martin, the firm leverages deep expertise in USP standards and FDA/ICH guidelines to ensure compliance and efficiency in drug testing. They assist clients in navigating the complexities of IND, NDA, and BLA filings, particularly regarding the analytical sections of the Common Technical Document.