Regulatory Affairs

pharma_photo2Our global-minded regulatory affairs staff has experience in the development of submission strategies that expedite agency review. Ceutical Laboratories, Inc. provides full-service regulatory consulting for integrated planning, management and preparation of preclinical development plans, chemistry manufacturing and control (CMC) or chemistry development, and international regulatory strategies, including:

  • Development of preclinical plans and comprehensive preclinical development services to support first-human studies and global registration — specifying studies needed, costs and timelines in the preclinical phase, including preparation and management of investigational new drug applications (INDs)
  • Preparation and management of marketing authorization applications (MAAs) and new drug applications (NDAs) and their maintenance
  • Experienced guidance in setting appropriate specifications, method development and validation, and conduct of stability studies for successful submissions
  • Preparation of all major regulatory submissions and expertise in multinational submissions
  • Providing expertise for international regulatory affairs
  • Regulatory strategies that help you prioritize projects with the greatest chance for approval and facilitate product authorization by regulatory agencies
  • Skilled technical writing as an integral part of a full drug development program, or as a standalone service
  • Compliance audit services

Clinical Study Programs

We support your clinical study programs with:

  • Preparation and review of IND and other clinical trial applications/notification
  • Effective communications with regulatory authorities
  • Maintenance and archiving of documents, interpretations and action and correspondence
  • Import licenses and export permits
  • Review of labeling for clinical trial material
  • Review of protocol packages
  • Training

Experienced Liaison with Regulatory Authorities

The Ceutical Laboratories, Inc. regulatory affairs department is experienced in establishing a liaison with regulatory bodies in support of a wide variety of indications. We can represent or support you in meetings with regulatory agencies, for scientific advice and to define your regulatory strategy.

  • In the United States, our expertise in working with divisions of the FDA has proven successful for our clients’ programs.

Chemistry, Manufacturing and Control (CMC)/Chemistry and Pharmacy: Submissions Consulting and Support

Our regulatory affairs department supports your CMC development with:

  • Consulting and review of:
    • Synthesis and manufacturing
    • In-process controls
    • Release specifications
    • Analytical method development
    • Validation protocols and reports
    • Stability protocols, reports and statistical analyses
  • Review and preparation of drug master files (DMF)
  • Good manufacturing practices (GMP) consulting, auditing and training
  • Review and preparation of CMC sections of clinical trial and marketing applications
  • Identification and management of contract manufacturers or contract labs