Innovative Consulting Solutions
Indevric provides consulting services to pharmaceutical and biotech companies.
Let us lead your team on the path toward regulatory success. We help clients navigate the regulatory environment with creative regulatory strategies and leading regulatory interactions.
Our consultants are experienced in developing regulatory strategies and leading health authority interactions for clinical and nonclinical development for small molecules, antibodies (monoclonal and bi-specific), antibody-drug conjugates, recombinant proteins, cell and gene therapies, and drug/device combinations.
Regulatory Strategy
- Regulatory intelligence
- Regulatory Submission strategy
- Integrated Regulatory strategic document delivery
- Acting head of Regulatory Affairs
Regulatory Interactions
- Pre-IND Meetings
- Milestone (EOP2 or Pre-NDA/BLA)
- Other Type C or Type D meetings
- Drafting questions, sponsor positions and background briefing packages.
Regulatory Submissions
- Drafting and review IND sections
- Draft and Review CTA content
- Orphan Drug Designations
- Pediatric Plans (US and EMA)
- Review Marketing Applications