Clinical Development

We provide global end-to-end regulatory affairs support to ensure your clinical trials start on time and stay compliant

• Prepare and submit clinical trials applications to US FDA, Health Canada, EMA, China FDA and other regulatory Health Authorities.
• Manage Health Authority interactions and regulatory intelligence.
• Submit clinical trials applications according to EU-CTR guidelines.
• Writing and review of study documents such as Study Protocol, Clinical Evidence Reports, Investigator Brochure, Module 2 Summaries, General Investigational Plan, Informed Consent Forms.
• Review CMC package.
• Prepare investigational product labelling.
• Prepare and coordinate Health Authority meetings.
• Manage submissions during clinical development lifecycle: amendments,  notifications and study reports.
• Support with open-label extension studies and post-trial access.

We navigate global requirements and implement a robust strategy to reduce delays, mitigate risks, and accelerate approvals - so you can focus on running your study. 

• Prepare and implement regulatory strategy plan for clinical development program until product registration, to ensure it addresses Health Authority potential queries, reaching successful approval.
• Work with cross-functional teams to ensure data robustness.
• Provide study teams with relevant regulatory guidelines to ensure compliance.

We provide specialised project management for clinical trials, ensuring every phase - from startup to closeout - runs on time, on budget, and in full compliance

• Coordinate and lead local regulatory teams and CRO to ensure strategy is implemented correctly and on time.
• Align cross-functional teams and coordinate strategy implementation.
• Track milestones, manage timelines and issue resolution.