Need support in the regulatory process? Let Akesis be your guide.

Our team is composed of highly qualified and seasoned individuals with intimate working knowledge of the FDA. These professionals advise on the most efficient way to design and conduct your development program to maximize success during all phases, from pre-clinical to post-approval, expediting products through clinical trials and into the market. We help clients develop strategies, examine alternatives, and identify tactics to deal with ever-changing regulatory pathway.



At Akesis, we understand the critical importance of complete and accurate regulatory submissions and collaborate on submission planning and preparation. We perform critical writing and pre-submission reviews of key technical documents to ensure consistency, scientific accuracy, completeness, and regulatory compliance. Our experience is strengthened by the contributions of our strategic partners, who are experts in the fields of data management and biostatistics, drug modeling and simulation analyses, medical writing, and packaging and label consultancy, among others.

Folders

Stethoscope
  • CMC, nonclinical, clinical and submissions
  • Compliance audits
  • Life cycle management
  • Pre and post-launch strategies
  • Regulatory and drug development guidance
  • Regulatory liaison
  • Maintenance of Archives for regulatory authority correspondence, meeting minutes, dossiers, and documents
  • Post-meeting analysis, response and dispute resolution
  • Meeting preparation and rehearsals, correspondence, meeting minutes, dossiers, and documents meetings
  • Preparation and submission of Pre-IND, EOP2, pre-NDA/BLA Briefing Documents
  • Compilation, preparation, submission and follow-up responses to Agency
  • Health Authority requests for information and action letters
  • Fast track and orphan applications
  • Maintenance of 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
  • Akesis provides experts to assist your company in mock regulatory audits, review of your quality systems including your CAPA plans, or any of the following services.

    • Site Quality Audits
    • GLP Audits
    • GCP Audits
    • CMC Reviews
    • GMP Inspections
    • QA Training