Quality & Regulatory Affairs

Design and execution of the regulatory strategies to obtain the sanitary registration of pharmaceutical, biotechnological, biological, cosmetic, food supplements, and medical devices (all classes)

  • Guidance on the necessary permits and procedures for the operation of the client’s institution, sanitary licenses, and applicable regulations.
  • Course-workshops for the design and application of regulatory requirements in the organization.
  • Design and preparation of documents (Dossiers, Manuals, Procedures, Instructions, Formats, etc.) that meet regulatory requirements.
  • Assistance in the preparation of documentation required by regulatory entities such as COFEPRIS (México), FDA (USA) and EMA (Europe), and including all the regulatory agencies that have adopted ICH.
  • Guidance on regulatory compliance audits through a preparatory mock audit that can be documentary, on-site, or both.
  • Explanation on the submission process in COFEPRIS in order to obtain a Marketing Authorization
  • Expert review on regulatory documentation (CTD Dossier) and help in the preparation for CODEBio and New Molecules Committee meetings for biotechnology products submission to COFEPRIS