- Overview
- Our Capabilities
- Why Choose Us
Overview
The journey from laboratory to clinic typically spans 10-12 years for a medicine to progress through the entire development process. Throughout the process, and even after a new medicine reaches the market, a significant amount of legislation is still required to ensure its safety and efficacy. Regulatory affairs, as the name suggests, encompasses all the regulatory protocols surrounding medicine development and ensures compliance with these protocols at every stage of the development.
Meticulous management of regulatory affairs can significantly boost the pace of clinical development, reduce costs, and streamline the lab-to-market process. Our expert consultants understand the importance of sound regulatory strategies for successful product development, and offer operational support that aligns with your goals. Our goal is to expedite the product launch process seamlessly and efficiently by implementing a well-developed plan, an appropriate regulatory strategy, and a high-quality dossier. If you have any need, please contact us.
Our Capabilities
Regulatory Consulting
- Product development and registration consultant
- Registration feasibility assessment
- Regulatory strategy and plan
Chemical Drugs and Biological Products Registration
- Submission dossier preparing
- Gap analysis
- Investigational applications (Pre-IND, IND, Pre-submission requests, IDE, ITA, CTA)
- Marketing applications (Pre-NDA , NDA, BLA, ANDA, PMA, MAA)
- DMF/CEP registration
- QC testing arrangement
- Renew & variation application
- Regulatory strategy development
Why Choose Us
- Our team of experts understands the importance of a robust and sound regulatory strategy for successful product development. We provide operational support that aligns with your goals and accelerates the product launch process smoothly and efficiently.
- Our capabilities range from basic regulatory consulting to more complex tasks such as product registration, gap analysis, preparation of submission dossiers, and management of investigational and marketing applications. We also have expertise in chemical drugs and biological products registration.
- We customize regulatory strategies for each client to ensure that your specific needs and objectives are met.
- Our global reach allows us to stay updated on the latest regulatory trends, ensuring your product adheres to all relevant regulations worldwide.