Regulatory Affairs
"Guiding your products through the complexities of global regulations with precision, expertise, and unwavering compliance"
Regulatory Strategy Development
“Your Pathway to Global Market Success.”
A well-crafted regulatory strategy is crucial for navigating the complex landscape of regulatory requirements and ensuring the successful approval of your product. It serves as a roadmap for the development, approval, and market access of pharmaceuticals, biologics, or medical devices, minimizing risks and maximizing efficiency.
At CliniResource, we take a comprehensive, tailored approach based on your product’s therapeutic area and target markets, to regulatory strategy development, helping you navigate the ever-changing regulatory environment with confidence. We are committed to helping you navigate regulatory complexities and achieve successful market access with confidence.
Regulatory Submission
“Precision and Excellence for Seamless Approvals.”
CliniResource offers expert guidance and regulatory submission support throughout the entire development and launch processes within UK, EU, US and Asia-Pacific. Our experts plan and coordinate every detail of a clear and complete US/UK/European submissions.
We provide consulting services for (key submissions).
Pre-Approvals examples
- Filling of Investigational New Drug (IND),
- Orphan Drug Designation (ODD),
- Biologics License Applications (BLA),
- Investigational Device Exemptions (IDE)
- CE filings and Pre-Market Approval (PMA)
MAA / NDA examples
- New Drug Application (NDA)
- Abbreviated New Drug Application (ANDA)
- Marketing Authorization Applications (MAA) within EU
- ATC code applications
Post-Approvals example
- Variations/Renewals
- MA transfers
- Reclassifications
Compliance Management
“Ensuring Integrity and Excellence Across Operations.”
In today’s highly regulated industries, ensuring compliance with ever-evolving standards is essential for safeguarding product integrity, protecting public health, and maintaining market access. Effective compliance management minimizes risks, prevents costly delays, and ensures that your products meet the highest safety and quality standards.
At CliniResource, we understand that compliance management is not just about meeting regulations—it’s about building trust, protecting your brand, and ensuring long-term success. With our expert team, tailored strategies, and commitment to excellence, we provide the regulatory solutions you need to stay compliant and competitive in the global market.
Regulatory Intelligence
“Empowering Informed Decisions for Market Success.”
Our dedicated team meticulously monitors global regulatory landscapes, ensuring that our clients stay abreast of any changes. We provide timely updates on regulatory discussions, decisions, and safety-related recommendations for products/molecules authorized on behalf of our clients. Through detailed meeting minutes, we keep our clients and their teams well- informed.
Responses to Health Authorities
“Ensuring Accuracy, Compliance, and Timeliness.”
Our highly skilled team, well-versed in all aspects of regulatory communications and feedbacks, supports clients in crafting and managing comprehensive responses to inquiries from Health Authorities. These responses may pertain to product safety issues arising from any pre authorisation and post authorisation submissions. Additionally, we assist in preparing letters in response to recent regulatory inspections or commitments made during prior regulatory inspections.