Regulatory Affairs Service

• 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