About our list of Services

Use the column to the left to read important details and topics regarding each service in particular

We ecourage you to contact Ocean Blue Medical Research Center for more questions and/or information about our services.

Regulatory Affairs

Our mission coincides with our vision: through our company values and the entire regulatory process, to translate research and development compounds into quality medicines for patients in the most efficient manner for our clients.

The Ocean Blue Medical Research Center Regulatory Affairs Department is composed of people with many years of experience gained within major pharmaceutical firms, academia and clinical research institutions. Our combined experience covers all major therapeutic areas of research and development as well as other regulatory expertise such as chemistry, pharmaceutical/CMC documentation, pre-clinical and clinical expertise.

The Regulatory Affairs Department adds value to drug development at Ocean Blue Medical Research Center through:

  • Understanding and interpreting the regulatory environment
  • Drug development experience
  • Significant expertise in clinical development/management and smooth transitions from exploratory to confirmatory stages of investigational drugs

Global Reach

With offices and employees providing global reach, Ocean Blue Medical Research Center' Regulatory Affairs Department is able to provide a crucial link with the major regulatory authorities and is skilled in the preparation, coordination and management of complex multinational submissions and meetings.

Drug Development with Emphasis on Clinical Trial Management

Our regulatory group is a team of competent professionals with many years of industry experience who can shape project plans to meet diverse regulatory requirements. Our experts know the most efficient route from bioanalytical, early phase clinical development, clinical development and peri-approval to successful marketing applications, while providing the necessary guidance to ensure continued regulatory compliance.

Our regulatory affairs activities embrace all types of projects, from global submissions to specialist consulting services. The two-armed department composed of the Regulatory Affairs Country Specialists and the Regulatory Affairs Strategy Group aims to provide integrated service both in terms of clinical trial management and consulting for regulatory processes.

Last update: 07/7/2015 11:24
Content updated on Monday, 10-2-2017 04:35:40 am