Global Regulatory Affairs Support

A smoother path to regulatory success 

Our Global Regulatory Affairs (GRA) support service is designed to guide you  through every stage of your discovery and development journey - helping you to reduce risks, accelerate timelines, and increase your chance of success at every step. 

From discovery and early-stage development to large-scale manufacturing and clinical trials, our innovative strategies and integrated solutions are designed to empower biotechnology and pharmaceutical companies - all the way from concept to cure.

Bringing new drugs to market has always been a challenge. With new modalities such as biologics or cell and gene therapies on the rise, the regulatory pathways become even more challenging because they often still need to be designed and discussed early in development with the regulatory bodies.

We at Evotec understand what it takes to bring a new drug to market from both a scientific and a regulatory perspective because we have everything you need for discovery, development, and regulatory success under one roof.

We can help you developing a smooth and straightforward strategy for your product by guiding you through the IND submission process, including any meetings with regulatory authorities or consultation as we recommend them when providing you with the strategic view. 

Our global regulatory affairs team manages your projects, whether integrated or stand-alone, as carefully and with the same dedication as our internal proprietary R&D projects. We treat your project as if it was our own.

Together with your experts, we prepare the best applicable strategy and we take care of your regulatory submissions; we are  at your side when it comes to preparing and facilitating the necessary meetings with regulators. All in an agile, flexible, and adaptable manner.

All modalities welcome

We offer support, insight, and expert guidance for a full range of modalities, from small molecules and mAbs to oligonucleotides and even the newest advanced modalities such as cell and gene therapy. We can support you in defining the orphan status of your product and opening an accelerated and incentivized development and approval for high unmet medical need products.

End-to-end support

Evotec’s Global Regulatory service team can support you throughout your entire discovery and development journey; ensuring sound regulatory strategy is built into your R&D program from day one. 

We provide you with tailored regulatory strategic input and support from detailed needs analysis and the definition of the target product profile, right through to support with health authority meetings, and complex regulatory submissions.

How can we help?

Evotec offers Global Regulatory Affairs support, guidance, and expertise at every stage of your R&D program across three key areas: Strategic input, health authority interactions, and document management.

Strategic input
  • Provide regulatory input to support your Product Development Strategies
  • Contribute to strategies improving the efficiency of product development and for accelerating the access to market
  • Provide regulatory input to support the design of successful clinical trials
  • Ensure you are always equipped with the very latest information by continuous monitoring of trends in regulatory sciences and ensuring we respond to these trends with state-of-the-art solutions at your hand
Health authority interactions
  • Clinical trial submissions in EU (CTA/CTIS) and in US (IND)
  • Worldwide submissions (ex-US and ex-EU) either via internal support, or by engagement of third parties
  • Orphan drug designations
  • Being the Point of Contact (PoC) on your behalf and lead the Communications with EMA, FDA or local regulatory agencies for regulatory related activities
  • FDA meetings (e.g., pre-IND, other Type A, B or C meetings, Advisory Committee)
  • Scientific Advice and Protocol Assessment meetings at central level at EMA/CHMP and at local agency’s level
  • Manufacturing facilities registration at the agency
  • US Agent function (Evotec, with the Evotec US site, can act as a US agent for clients who do not reside in the US)
Document management
  • Authoring, reviewing, publishing, and submitting:
    • IND/IMPD dossier
    • CTA/CTIS
    • DMF/ASMF/ANDA and generic products EU submissions
  • Investigator’s Brochure edition/review
  • Review of clinical trial protocols for regulatory compliance
  • Development of easy-to-use templates with built-in styles for headers and footers, headings, table, and figure titles, as well as including proposed content
  • Preparation and submission of Orphan Drug Designation reports (EU and US)

Contact us


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