- Cyntax Health Projects specialize in Regulatory Affairs & Compliance, providing expert guidance to pharmaceutical, biotechnology, and healthcare companies to ensure their products meet global regulatory standards. Our team of regulatory professionals ensures seamless approvals, compliance with industry guidelines, and efficient market access for pharmaceuticals, nutraceuticals, and medical devices.
- We provide comprehensive regulatory solutions to help businesses navigate complex approval processes, maintain compliance, and achieve long-term market success. Whether you are launching a pharmaceutical drug, nutraceutical supplement, or medical device, our expert team ensures a smooth and hassle-free regulatory journey.
Regulatory Strategy & Consultation
- Expert guidance on drug, supplement, and medical device regulations
- Compliance with FDA, EMA, DRAP, WHO, and ICH-GCP standards
- Assistance with market entry and product registration
Regulatory Submissions & Approvals
- Preparation and submission of CTD/eCTD dossiers
- IND, NDA, ANDA, and MAA submissions for drug approval
- Regulatory filing for nutraceuticals and medical devices
Product Labeling & Market Authorization
- Compliance with local and international labeling regulations
- Assistance with advertising claims and product classification
- Ensuring accurate and regulatory-compliant product packaging
Risk Management & Regulatory Intelligence
- Monitoring and adapting to evolving regulatory landscapes
- Risk assessment and mitigation for product compliance
- Continuous support for post-approval regulatory requirements
Infectious & Non-Communicable Disease Research
- Studying disease burden, transmission, and prevention
- Researching chronic diseases like diabetes, cardiovascular diseases, and cancer
- Supporting the development of vaccination and public health initiatives