From study design to market submission, every development step matters.
Our regulatory consultants help you build a strategy that’s both scientifically sound and globally aligned. We provide the expertise you need to move from concept to approval – faster, smarter and with confidence.
Why choose Clinigen
- Strategic expertise from early-stage planning to regulatory submission
- Proven track record across IND, NDA, BLA and MAA pathways
- Integrated support across CMC, non-clinical and clinical domains
Our expertise includes
Global submission strategy
- IND, NDA and BLA preparation (FDA)
- MAA support (EMA, MHRA and national EU agencies)
- PMDA (Japan)
- Strategic planning and agency liaison
- Clinical trial alignment and study readiness
- Regulatory interactions and authority engagement
- Module-specific review and refinement
Scientific and medical advice
- Scientific Advice and Protocol Assistance (EMA, FDA, MHRA)
- Preparation for mock and formal agency meetings
- Articulation of scientific rationale and value
- Strategy development for expedited pathways (PRIME, Breakthrough, Accelerated Approval, etc.)
- Joint Scientific Consultations
Protocol assistance and study design
- Study design and endpoint selection
- Development of original protocols and amendments
- Feasibility review and regulatory alignment
- Focus on scientific integrity, patient safety and approval likelihood
Non-clinical and clinical development consulting
- Development–Regulatory Roadmaps tailored to product objectives
- Support across antibodies, ADCs, ATMPs, biologics and biosimilars
- ATMP classification and agency engagement
- Biotech-specific regulatory strategy
Regulatory due diligence & gap analysis
- Acquisition and licensing support for biotechs and investors
- Review of CMC, clinical, non-clinical and regulatory documentation
- Identification of risks, opportunities and strategic gaps
- Alignment of development and commercial objectives
Looking for guidance on your drug development strategy?
We support biotech innovators with hands-on guidance, clear timelines and global regulatory insight.