Regulatory Support

Bringing new drugs to the market has always been a challenge. With modalities like biologics or cell and gene therapies, the regulatory pathways have become even more complex. Often, these pathways need to be designed and discussed early in the development process with regulatory bodies.

At Evotec, we understand the requirements for successfully bringing a new drug to market from both scientific and regulatory perspectives. We have everything you need for discovery, development, and regulatory success, all under one roof.

We can assist you in developing a seamless and straightforward strategy for your product by guiding you through the IND submission process. This includes arranging meetings with regulatory authorities and providing consultation, as recommended, to offer you a strategic view.

Our global regulatory affairs team manages your projects with the same level of care and dedication as our internal proprietary R&D projects. We treat your project as if it were our own.

Working alongside your experts, we prepare the most effective and applicable strategy, while taking care of your regulatory submissions. We are by your side when it comes to preparing and facilitating the necessary meetings with regulators, ensuring an agile, flexible, and adaptable approach

We provide comprehensive assistance, profound understanding, and expert direction for a wide spectrum of modalities, encompassing small molecules, monoclonal antibodies (mAbs), oligonucleotides, and cutting-edge advancements like cell and gene therapy. Our services extend to aiding you in delineating the orphan status of your product and facilitating an expedited and incentivized development and approval process for medical products addressing significant unmet needs.

Our Regulatory team can provide comprehensive support throughout your entire R&D process, ensuring the integration of a robust regulatory strategy into your program from its inception. Our team offers personalized regulatory strategic input and assistance, starting with a thorough needs analysis and the definition of the target product profile. We continue to support you through health authority meetings and the preparation of complex regulatory submissions.

We offer 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. 

• Offer regulatory expertise to enhance Product Development Strategies
• Contribute to strategies aimed at enhancing the efficiency of product development and expediting market access
• Provide regulatory guidance to facilitate the design of successful clinical trials
• Ensure access to the most up-to-date information through continuous monitoring of regulatory science trends, enabling us to provide cutting-edge solutions

• 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 
• Point of Contact (PoC) on behalf of our partners and manage 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
• US Agent function (through our US site, we can act as an US agent for partners who do not reside in the US) 

• Authoring, reviewing, publishing, and submitting: 
  • IND/IMPD dossier 
  • CTA/CTIS 
  • DMF/ASMF/ANDA and generic products EU submissions 
• Investigator’s Brochure editing/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 inclusion of proposed content 
• Preparation and submission of Orphan Drug Designation reports (EU and US)