Regulatory Affairs and Medical Writing

Our Regulatory Consulting services include regulatory guidance, strategy building, and problem-solving, and range from the development of ad-hoc regulatory tactics to the creation of comprehensive development programs. Our commitment to our staff professional development and our collaboration with national and international regulatory authorities regarding new standards, allow us to offer first-class guidance.

Key Services

  • Regulatory Consulting
    • Design and implementation of regulatory strategies
    • Optimized strategy based on each FDA Center’s expectations
    • Guidance on the latest regulatory issues and requirements
    • FDA negotiations and appeals

Our regulatory experts guide you through the preparation, coordination, publishing, and submission of regulatory documents such as your study protocol, informed consent forms, clinical study reports, Standards Operating Procedures (SOPs), and much more. We assist you in your Investigational New Drug (IND), pre-IND, New Drug Application (NDA), Investigational Device Exemption (IDE), and pre-IDE application by conducting evaluations, planning meetings, developing briefing packages, and drafting reports and other critical documents.

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