Omni Early Development Services
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Regulatory

Nothing can be more devastating to an early development project than a clinical hold. To avoid holds, biopharmaceutical companies regardless of size, need experienced regulatory affairs assistance. Our regulatory affairs team has both strategic and operational experts. From identifying a regulatory strategy to submitting through an electronic gateway, we can help you manage all your regulatory requirements.

Regulatory Strategy & Representation

Gaining approval from regulators requires a strategic approach which ensures the product development rationale is clearly communicated and interpretation of regulations is properly applied. Omni-EDS regulatory experts add strategic insight and exceptional experience to all stages of product development and commercialization. Learn More

Regulatory Operations

Drug development is a highly regulated industry. Omni-EDS regulatory personnel are experts in understanding and ensuring compliance with the regulations. As a member of your team, they play a critical role, not only as the interface with drug regulators, but also as a link between different disciplines in the development process.​ Learn More

Regulatory Submissions

Our submission teams have the know-how to develop and publish regulatory submissions including Orphan Drug Applications, pre-IND Packages, IND Applications, Annual Reports, CSR’s etc. ​Learn More

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  • Home
  • Drug Development
    • Pre-clinical
    • CMC
    • Clinical
  • Regulatory
    • Strategy & Representation
    • Operations
    • Submissions
  • Medical Writing
    • Regulatory & Clinical
    • Scientific Grant
    • Scientific Manuscript