REGULATORY SUPPORT AND COMPLIANCE
Bridging The Gap
ZUVCHEM’s Quality, Regulatory, and Business Development teams serve as dedicated advocates—bridging the gap between global API and nutritional ingredient manufacturers, U.S. regulatory authorities, and our valued clientele. We aim to deliver APIs and nutritional ingredients on time, every time, in full compliance with regulatory requirements.
We maintain detailed, product-specific regulatory & quality data to ensure a smooth transition from manufacturing to market. With robust systems that uphold data integrity, our integrated approach to sourcing, logistics and sales ensures end-to-end regulatory compliance across the entire supply chain.
Navigate Regulations with ZUVCHEM
- Global Expertise: Decades of experience in US and international regulatory compliance.
- Strategic Partnership: We manage regulatory complexities so you can focus on innovation.
- Precision and Compliance: We ensure accuracy and timeliness from DMF submissions to post-approval updates.
- Comprehensive Support: Assistance across all stages of development, registration, and market maintenance.
Industry Insights and Resources
Stay informed with ZUVCHEM’s latest regulatory updates:
- Understanding Application and Approval Processes.
- Challenging Regulatory Landscapes and Available Opportunities
- The Shift Towards Reshoring Manufacturing of API and Nutritional Ingredients.
- The Future of Global Drug Supply Chains.
REGULATORY SUPPORT
ZUVCHEM offers a full spectrum of regulatory services, leveraging global expertise to facilitate regulatory compliance with the USFDA, USDA, USEPA, and international regulatory frameworks. We provide structured guidance to help manufacturers navigate the regulatory landscape with confidence and efficiency.
SIMPLIFYING COMPLIANCE
Navigating the complex and evolving regulatory landscape in pharmaceuticals and nutraceuticals requires precision and expertise. We streamline this process for foreign API and nutritional ingredient manufacturers, providing specialized regulatory support to ensure smooth and timely market entry in the United States. Headquartered in New Jersey, our experienced regulatory team acts as your strategic partner, managing compliance across all stages—from ingredient sourcing to final product delivery
Regulatory Authority Liaison Services
- Acting as the US Agent for foreign manufacturers, coordinating interactions with regulatory authorities and clinical trial partners.
- Streamlining the submission process and regulatory correspondence to expedite approvals.
US FDA Registrations
- Facility registrations for nutritional ingredient suppliers entering the US market.
- Drug establishment (FEI) registrations for API and pharmaceutical manufacturers.
- National Drug Code (NDC) registrations for accurate product tracking.
US EPA Pesticide Registrations
- Regulatory assistance for rodenticide and pesticide manufacturers to meet US-EPA environmental compliance standards.
Due Diligence and Documentation Reviews
- Thorough evaluation of regulatory compliance documentation to identify potential risks and ensure readiness for approval.
- Critical analysis of drug substance and drug product dossiers to align with regulatory standards and expectations
Drug Master File Submissions
- Preparation, compilation, and submission of Veterinary Master Files (VMF) and Drug Master Files (DMF) for API manufacturers.
- Ensuring thorough documentation to facilitate regulatory approvals.
GMP and Compliance Standards
- Ensuring adherence to Good Manufacturing Practices and US-FDA, USDA, US-EPA, and US-DEA regulatory guidelines.
- Advising on analysis and recommending resolutions to maintain product integrity and regulatory alignment.
Importer of Record (IOR) Management
- Continuous compliance monitoring and maintenance of IOR registrations with the US-FDA to ensure uninterrupted import processes.