Navigating the Path to Market with ESTERN Medical CRO Life Sciences
At ESTERN Medical CRO Life Sciences, our regulatory and safety guidance oversight services seamlessly integrate into the pharmaceutical or medical device development process, ensuring a smooth journey from inception to market release.
Expertise in Regulatory Landscape:
Our regulatory team boasts a broad track record of experience and established relationships with numerous regulatory agency divisions in the US, North America, and Latin America. This allows us to collaboratively explore options with clients, charting the most efficient route and ensuring the shortest timeframe to bring their products to market.
Global Regulatory Insight:
With experience in the US FDA, Latin American, and European regulatory authorities, we bring a deep understanding of therapeutic areas and regulations. From Common Technical Document (CTD) requirements to the US, LATAM, and European Clinical Trial Directive, our expertise guides Sponsors through the intricacies of regulatory processes.
Proactive Issue Resolution:
Anticipating potential issues, our team develops proactive strategies to address challenges early in the process. Our knowledge of local market requirements in key regions across the US and Latin America allows for simultaneous registration applications, providing a strategic advantage.
Strategic Planning for Success:
We initiate the process with strategic regulatory, scientific, and safety planning during the clinical trial phase. Collaborating in the study design, we integrate a comprehensive understanding of current regulations and the regulatory environment from start to finish. This approach ensures a smoother and more efficient drug development process.
Global Regulatory Knowledge:
ESTERN Medical Regulatory Affairs team possesses daily-use knowledge of regional regulatory requirements worldwide. We offer competitive product development plans, rapid study startup, and effective submission strategies. Close collaboration with multi-functional project teams supporting Early Clinical Trial Development, Product Registration, and Late Phase trials, along with partnerships with ESTERN Medical Analysis & Reporting and Safety & Risk Management groups, ensures successful development programs.
Comprehensive Regulatory Services:
We provide international consulting services and develop strategies for the registration of clinical trials for a diverse range of products, including novel products, biotechnology therapeutics, advanced therapeutics, new chemical entities, biologicals, and medical devices. Our teams, with backgrounds in pharmaceuticals, biotechnology, medical device companies, other CROs, regulatory agencies, and academic institutions, contribute to our holistic approach.
Key Regulatory Services:
- Regulatory lifecycle management
- Regulatory strategic development
- IND/NDA/CTA/510K/PMA submissions/maintenance
- Orphan Applications
- Agency meeting preparation
- Marketing authorization applications
- Agency Liaison
Choose ESTERN Medical CRO for comprehensive regulatory services that guide your product from discovery through clinical development, market approval, and post-marketing studies. Our commitment to regulatory excellence ensures a robust and efficient pathway to market success.
