The Regulatory Affairs & Quality Assurance/Quality Control Practice works with biotechnology, pharmaceutical, medical device and medical diagnostics companies on project management, regulatory strategy, the institution of internal quality programs, auditing services and technical writing.

Our Regulatory Affairs professionals provide our clients with:

  • Regulatory strategy development, to move research programs and their products into clinical trials in accordance with national and international requirements.
  • Timely review and approval of submissions, by coordinating interactions with regulatory agencies.
  • Successful initiation and completion of trials, by compiling, submitting and maintaining INDs for all phases of clinical studies.
  • Development of international regulatory strategic plans.
  • FDA meetings, coordinated, prepared and attended by Clinquest.
  • Writing and review of regulatory submissions, including INDs, NDAs, BLAs, PMAs, ANDAs and supplements.
  • Preparation of orphan drug applications.
  • Post-marketing reporting requirements services, including annual reports, periodic reports, field alerts and promotional material review and submission.
  • U.S. Agent, for foreign establishment services.
  • Guidance and recommendations, for structure and operation of clients' regulatory affairs departments.
  • Personnel training on regulatory topics.

Our clinical Quality Assurance professionals ensure current Good Clinical Practice (cGCP) compliance across our clients¹ clinical programs. Our manufacturing and preclinical Quality Assurance professionals implement systems to meet the requirements of current Good Laboratory Practices (cGLP) and current Good Manufacturing Practices (cGMP).

Our clinical Quality Assurance professionals provide our clients with:

  • SOPs.
  • Personnel training on clinical quality assurance topics.
  • Central Medical File (CMF) set-up.
  • Site audits.
  • Central laboratory and vendor audits.
  • Data management audits.
  • Tables and listings audits.
  • Our preclinical Quality Assurance professionals provide our clients with:
  • Assay design and validation.
  • GLP validation.
  • Auditing of current internal programs.
  • Auditing of vendor facilities, including:
    • Preclinical testing labs for GLP
    • Facilities for GMP