Regulatory Affairs

Our team of scientists—toxicologists, chemists, pharmacologists, and regulatory affairs professionals—work closely to develop and implement viable strategies to move projects from conception to approval. As a government contractor, we currently manage INDs for approximately 100 clinical trials. A number of clinical studies under these INDs are considered registration studies by pharmaceutical partners. For non-government clients, we have collaborated on INDs, DMFs, and NDAs.

Our Services:

• Regulatory Services for Clinical Investigation of Drugs
• Preparation, Submission, and Maintenance of INDs and DMFs
• Strategic Planning for Clinical Development
• Nonclinical Study Design and Management
• FDA Meeting Planning and Participation
• Protocol Development
     – Concept Development
     – Design, Preparation, Review of Protocols
  
• Informed Consent Design/Review by Certified IRB Professional
• Regulatory Document Collection, Review, and Maintenance Through All Phases of Study
• Development of Study-specific Regulatory Guidelines and SOPs
• Regulatory Review of Clinical Trial Reports, Including Final Reports
• Consultation for Federally Funded Clinical Studies, Including OHRP Assurance
• Investigator and Site Selection, Eligibility Validation
• Pharmacovigilance
     – Adverse Event Review
     – SAE Reporting and Follow-up
     – Safety System/Database Design
  
• NDA Development