REGULATORY SCIENCE &
HEALTHCARE POLICY

Our experts can help you devise effective regulatory strategies to place you on the best path toward regulatory approval.

ADVICE ON

• EU/USA device regulation
• Device-drug combinations
• Validation of remote monitoring devices

STRATEGIC ADVICE FOR REGULATORY MEETINGS

• Identification of critical points
• Review of documents
• Participation in meetings
• Debriefing

SUPPORT SCIENTIFIC ADVICE PROCESSES INCLUDING RESPONSE TO REGULATORY LISTS OF QUESTIONS

SUPPORT FOR ORPHAN DRUG
REGULATORY PROCESS

• Orphan Drug Designation
• Rare Pediatric Disease Designation & Priority Review Voucher Programs
• Protocol Assistance / Scientific Advice

ASSISTANCE IN DEVELOPING REGULATORY SUBMISSION DOCUMENTS

• EMA: SME statutes, scientific advice, PRIME (priority medicines), CTA, CTD, PIP.
• FDA: scientific advice, Fast track designation, breakthrough therapy designation, priority review, accelerated approval, IND, BLA/NDA
• ANSM: Scientific Advice (GIO)

OUR SERVICES

POLICY AND REGULATION DEVELOPMENT

Research and Analysis: Conduct through research on existing regulations and policies.

Stakeholder Consultation: Engage with stakeholders to gather insights and feedback.

Impact Assessment: Setting up a regulatory strategy

REGULATORY SUBMISSIONS AND APPROVALS

Preparation of Submissions: Compile necessary documentation for regulatory submissions and take care of administrative process with regulatory agencies

Compliance Review: Ensure that all submissions comply with relevant regulatory requirements and guidelines.

Regulatory Interactions: Manage interactions with regulatory agencies.

IMPLEMENTATION AND MONITORING

Training: Conduct training sessions to ensure proper understanding and adherence to new regulations and policies.

DO YOU HAVE A PROJECT ?

Our team of experts is here to discuss it with you!