Regulatory Affairs

510k          505(b)(2) NDA          ANDA          GCP/GLP/GMP Auditing Servcies

Akesis provides regulatory consulting as a customized stand-alone service or through our full service clinical trials.
Regulatory Consulting and Strategy (pre and post-approval)

• CMC, nonclinical, clinical and submissions
• Compliance audits
• Life cycle management
• Pre and post-launch strategies
• Regulatory and drug development guidance
• Regulatory liaison

Regulatory Meetings

• Maintenance of Archives for regulatory authority correspondence, meeting minutes, dossiers, and documents.
• Post-meeting analysis, response and dispute resolution.
• Pre-IND, EOP2, pre-NDA/BLA Briefing Documents, meeting preparation and rehearsals, correspondence, meeting minutes, dossiers, and documents meetings (preparation and submission of requests and Briefing Documents.

Preparation, Submission and Maintenance of Marketing Applications

• Compilation, preparation, submission and follow-up responses to Agency
• Health Authority requests for information and action letters
• Fast track and orphan applications
• Marketing Application maintenance
            o (Amendments, Periodic Safety and Annual Reports, post-submission updates)
• Paper and/or eCTD formats
• Preparation of Regulatory Strategy Assessments
• Prepare CMC, nonclinical, clinical subsections and labeling
• Product Registration [NDA, ANDA, BLA, MAA]
• Review Statistical Analysis Plans, CMC, nonclinical and clinical study reports
• Submission planning and management
• US Agent services
"For more information on our Regulatory Services, email info@akesis.com; "