Your all-in-one guide for navigating Healthcare and Cosmetic Compliance & Regulations.
India Regulatory Services
We specialize in offering regulatory and compliance services in India. Navigating the intricate path from the inception of a concept to product approval can be challenging, particularly in light of rigorous regulations.
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Our Authorized Agent services offer you a strategic advantage, streamlining regulatory processes and ensuring compliance across borders.
Elevate your international market endeavors for Medical Devices.
Boost your efforts to expand into international markets with authorized agents for Drugs.
Enhance your global market initiatives with support and guidance of authorized agents
Unlock your global market opportunities effortlessly with assistance of agents for cosmetics.
We advocate against a one-size-fits-all approach. Our services are meticulously tailored to meet your unique requirements, guaranteeing your success in achieving your goals.
Our commitment lies in delivering value that goes beyond the confines of the immediate project, aiming to provide sustained benefits over the long term.
Our services are intricately designed to address your specific needs, fostering enduring success beyond the initial engagement. We prioritize the creation of lasting value, ensuring our solutions contribute to your sustained growth and achievement of objectives.
Contact UsWe specialize in facilitating various types of drug trials, including those for new drugs, fixed dose combinations, investigational new drugs, subsequent new drugs, and phytopharmaceutical drugs.
We provide assistance in implementing clinical investigation solutions tailored for medical devices. Our support encompasses comprehensive services aimed at ensuring the effective execution of clinical studies..
We specialize in in vitro diagnostics (IVD) solutions, offering expertise in the comprehensive evaluation of diagnostic performance. Our services encompass precise clinical investigations for IVD ...
We engage in studies encompassing Efficacy Evaluation, Safety Evaluation, Sensory and Performance Evaluation, and Product-Led Claims assessment.
Our comprehensive regulatory solutions encompass a wide spectrum of services and products, ensuring a simplified and supportive journey for our clients navigating complex regulatory landscapes. We are dedicated to facilitating ease, familiarity, and guidance throughout every step of the regulatory process.
In a fast-paced world where information shapes, our blogs keep you informed about the latest developments
On February 12, 2024, the Central Drugs Standard Control Organization (CDSCO) of India issued a notice to the various stakeholders in the medical device industry, emphasizing the importance of submitting applications for Neutral Codes solely through the Online System of Medical Devices portal.
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On January 01, 2024, the notice was issued by the Central Drugs Standard Control Organization (CDSCO) of India to all stakeholders, announcing the establishment of the National Single Window System (NSWS). This system aims to streamline investor approvals and simplify business transactions by serving as a unified platform for obtaining approvals, licenses, registrations, and clearances as required.
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Are you looking to venture into the medical device manufacturing industry in India? Understanding the regulatory landscape is crucial for success. Here's a concise guide on how to obtain a medical device manufacturing license in India. Firstly, classify your medical device according to its risk level, as per the Medical Device Rules, 2017. Classify it into Class A, B, C, or D based on factors like intended use and invasiveness.
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