Comprehensive Regulatory Affairs & Compliance Services
Our regulatory affairs team provides expert guidance and support for navigating complex global regulatory landscapes. We ensure compliance with FDA, EMA, PMDA, Health Canada, and other global health authorities throughout your product lifecycle.
Our experienced regulatory specialists maintain current knowledge of evolving regulations and provide strategic guidance for successful submissions and approvals.
We specialize in developing regulatory strategies for IND/CTA submissions, clinical trial applications, marketing authorizations, and post-approval requirements. Our team prepares comprehensive regulatory submissions, manages agency interactions, and ensures compliance with ICH guidelines and local regulations. We provide proactive regulatory intelligence and strategic planning to optimize your development pathway and accelerate market access.
Frequently Asked Questions
Q: What regulatory agencies do you support?
A: We support submissions and interactions with all major regulatory agencies including FDA (CDER, CBER), EMA, PMDA (Japan), Health Canada, TGA (Australia), MHRA (UK), NMPA (China), and other global health authorities. Our team includes region-specific experts with deep understanding of local requirements.
Q: Can you help with expedited regulatory pathways?
A: Yes, we have extensive experience with expedited programs including FDA Breakthrough Therapy, Fast Track, Priority Review, and Accelerated Approval pathways, as well as EMA PRIME, Conditional MA, and Accelerated Assessment. We develop strategic plans to qualify for these pathways and optimize regulatory success.
Q: How do you stay current with regulatory changes?
A: Our regulatory intelligence team continuously monitors regulatory updates through official agency websites, professional networks, regulatory news services, and participation in industry conferences. We maintain comprehensive regulatory databases and provide regular updates to clients on relevant changes affecting their products.
Our Regulatory Affairs Services Include
- Regulatory strategy development
- IND/CTA submission preparation
- Marketing authorization applications
- Agency meeting preparation and support
- Regulatory documentation review
- Post-approval regulatory compliance
- Labeling and promotional material review
- Regulatory intelligence and monitoring
