Regulatory Affairs Consulting & IND/CTA Submission Services
Global regulatory strategy, FDA and EMA interactions, and IND, CTA and IMPD dossier preparation for small molecules, antibodies, oligonucleotides and cell and gene therapies, integrated into your R&D program from early development onward.
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Regulatory planning often starts too late, and newer modalities make that more costly. Biologics, oligonucleotides and cell and gene therapies follow complex pathways that usually need early discussion with regulators. Evotec's global regulatory affairs team builds a regulatory strategy into a program from the beginning. It starts with a needs analysis and the target product profile, then supports health authority meetings and the preparation of complex submissions.
Evotec’s team works alongside the client’s own experts and can act as their point of contact with the FDA, EMA and national agencies. It can also serve as US Agent for companies without a US presence. Clients can combine regulatory support with Evotec's preclinical, clinical and CMC capabilities, which reduces the handovers between separate providers.
Evotec’s key capabilities include:
- Global regulatory strategy and development planning
- Regulatory input from early R&D through clinical development
- EU CTA/CTIS and US IND submissions
- FDA, EMA/CHMP and other health authority interactions
- Pre-IND, Type A/B/C and scientific advice meetings
- Orphan drug designation support
- Regulatory document authoring, review, publishing and submission
- Investigator's Brochure and clinical protocol review
- Manufacturing facility registration
- Regulatory support across small molecules, biologics, mAbs, oligonucleotides, cell and gene therapies
