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
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
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