Pharma Regulatory Services
End-to-End regulatory consulting for pharmaceuticals, medical devices and cosmetics - helping you achieve timely approvals, maintain compliance and accelerate market access.
Navigating today’s evolving regulatory landscape requires expertise, strategic planning, and proactive compliance. At Vaayath Regulatory Consulting, we provide end-to-end regulatory solutions for pharmaceutical, medical device, cosmetic, and nutraceutical companies entering and operating in the Indian market. From approvals, registrations, licensing, and documentation to authority interactions and compliance support, our experts simplify complex regulatory requirements, minimise risks, and help accelerate market access.
We guide manufacturers and importers through every regulatory requirement to enter and operate in the Indian market. Explore the individual services below.
New Drug Approvals
Accelerating Regulatory Approvals with Strategic Expertise. Bringing a new drug to the Indian market requires navigating a complex regulatory framework governed by the Central Drugs Standard Control Organization (CDSCO). From determining the applicable regulatory pathway to preparing comprehensive dossiers and coordinating with regulatory authorities, every stage demands technical expertise and meticulous planning.
Medical Device Regulatory Services
Obtain expert regulatory support for medical devices and IVDs under the Medical Device Rules, 2017. We assist manufacturers, importers, distributors and foreign companies with classification, licensing, import registration, ISO 13485 compliance, technical documentation, post-market obligations and lifecycle regulatory support.
Cosmetics Regulatory Services
Comprehensive regulatory consulting for cosmetics manufacturers, importers and global beauty brands under the Cosmetics Rules, 2020. We provide end-to-end support for import registration, manufacturing licences, label compliance, documentation, product safety and lifecycle regulatory compliance.
Import & Registration of Drugs
Comprehensive regulatory consulting for overseas pharmaceutical manufacturers and Indian importers seeking CDSCO import registration, import licences, registration certificates, technical documentation, and lifecycle compliance under the Drugs and Cosmetics Act, 1940 and Drugs Rules, 1945.
WHO-GMP and COPP filing
End-to-end regulatory support for WHO-GMP certification and Certificate of Pharmaceutical Product (COPP) applications through the ONDLS portal, including documentation review, online filing, authority coordination and post-approval support.
Regulatory Legal Services
Integrated Regulatory & Legal Solutions for Pharmaceuticals, Medical Devices, Cosmetics, Nutraceuticals and Healthcare Businesses. Whether you have received a Show Cause Notice, NSQ report, Stop Sale Order, Suspension Notice, Prosecution, Licensing Objection or Regulatory Investigation, our experts combine deep regulatory knowledge with legal strategy to protect your business and achieve practical resolutions.
Regulatory Retainership Services
Your Dedicated Regulatory Affairs, Compliance & Technical Advisory Team—Available Whenever You Need Us. Stay compliant without the cost of building a large in-house regulatory team. Our retainership provides continuous access to experienced regulatory professionals for compliance management, licensing, technical reviews, authority interactions, inspections, legal support, and strategic regulatory guidance.
Labelling Support Services
Ensure Every Label is Regulatory Compliant Before It Reaches the Market. Comprehensive Label, Artwork and Packaging Compliance Reviews for Pharmaceuticals, Medical Devices, Cosmetics, Nutraceuticals, Food Products and Healthcare Products. Prevent costly recalls, import detentions, product seizures, misbranding actions, and regulatory observations through expert review of labels, cartons, package inserts, promotional claims, QR codes, and artwork against applicable Indian regulatory requirements.
Export NOC Services
Expert Assistance for CDSCO Export NOC Applications. Exporting pharmaceutical products from India often requires obtaining a No Objection Certificate (NOC) from the Central Drugs Standard Control Organization (CDSCO), particularly for unapproved drugs, new drugs and banned drugs. Our experts assist with eligibility assessment, documentation preparation, online filing, authority correspondence, and follow-up to help ensure timely issuance of Export NOCs and uninterrupted international shipments.
Dual Use License Services
End-to-end regulatory support for obtaining CDSCO Dual Use Licences for import of drugs and pharmaceutical substances intended for industrial, research, veterinary, cosmetic and other non therapeutic applications.
Ready to navigate regulatory complexity with confidence?
Whether you are launching a new product, expanding manufacturing capabilities or strengthening compliance systems, our experts are ready to support your journey.