Strategic Regulatory Affairs

Complex oncology demands a team of experienced professionals who are in tune with the unique development and regulatory challenges. OncoBay Clinical’s way of approaching trial design ensures that you get the most aggressive path to regulatory approval while ensuring that all requirements are met along the way.
Strategic Regulatory Affairs

Capabilities include:

  • Consultation on strategic planning (Target Product Profile)
  • Consultation on design of your pre-clinical strategy
  • Evaluation of dossier against industry standards and regulatory requirements to pinpoint what may be missing for a successful submission (GAP analysis)
  • Consultation on the content, writing, and support for pre-IND submissions assuring that the client receives the constructive Agency feedback needed
  • Provide publishing support for regulatory submissions
  • FDA relationship management
  • Medical Writing – Essential regulatory, Medical, development, and pre-clinical

Take Advantage of OncoBay’s Innovative Approach


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OncoBay is now Kapadi


Once three entities – OncoBay Clinical, Clinscience, and Exom Group s.r.l – now we stand as one, bringing forth a symphony of expertise and seamless operations. To celebrate our unity, we re-brand under the banner of Kapadi, and embark on a new chapter of exceptional service in oncology clinical research.

Kapadi is not just a name; it's a testament to our fusion. It signifies the our standing as a global CRO powerhouse committed to accelerating groundbreaking cancer therapies that uplift patients worldwide. From conceptualizing studies, navigating regulations, and analyzing data, we provide a comprehensive array of services designed to empower your oncology clinical trials.




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