Regulatory Support
Bringing a new product from laboratory development to marketing approval is a lengthy and very expensive process. If any delays occur because of the regulatory issues could seriously cost the innovator in money and time.
Innovate Research Pvt. Ltd., is provides seamless, transparent and current good regulatory consulting services to clients across Pharmaceutical, Biotechnology, and API manufacture, Finished Formulations Manufacture, Medical Device, Food and Beverage companies.
Our approach is very simple. We understand each of our client’s needs in-depth and we analyze their regulatory needs. With advance planning and strong and stringent execution of regulatory filings in compliance with respective regulatory agencies, we provide global current regulatory support to our clients ahead of the time.
Our services range from a simple advisory service consulting to full IND, NDA and IDE preparation and submission, including submissions in electronic Common Technical Document (eCTD) format.
Highly experienced and broad knowledge Katalyst’s team members, including Clinical, Medical Safety, Data Management, Statistics and Project Management, are available to assist as single or as a completely manageable fully functional clinical development team to ensure successful product registration in American, European and all other global markets.
Innovate Research offers wide range of Regulatory Services
- Regulatory affairs: CMC, Dossiers
- Regulatory Strategy and Intelligence from Molecule to Market.
- Regulatory Submissions: IND, NDA, ANDA, BLA and CTA applications (Paper & eCTD)
- Regulatory Writing: Clinical and CMC
- Regulatory support for Clinical Trials
- Regulatory Operations: Clinical and Non-Clinical Publishing and Submission.
- Regulatory Labelling: Clinical and Non-Clinical
- Regulatory Agency Liaising
- Regulatory Business and Outsourcing Consultancy
Trusted Medical Device Regulatory Services & Submissions
Innovate Research is dedicated to helping innovators bring safe, effective medical devices to market with confidence. As a leading provider of medical device regulatory services, our expertise spans the entire lifecycle; from initial classification and documentation to regulatory submission and post-market support. We understand both India’s unique requirements and international standards, so your regulatory journey is streamlined and compliant from the start.
Every project benefit from our tailored guidance and rigorous approach. Fast, accurate, and fully compliant regulatory submission is our priority; giving you the best chance of approval with minimal delays, whether you’re targeting India’s CDSCO or global authorities.
Navigating Regulatory Submissions in India
Regulatory submission in India is a step-by-step process unique to every device. Our team partners with you throughout:
- Product Classification: Ensuring accurate device categorization under Indian Medical Device Rules.
- Technical Documentation: Comprehensive preparation and review of Device Master Files, safety and performance data, and essential clinical trial results.
- Dossier Submission: Navigating the portal for digital filings and liaison with regulatory authorities.
- Authority Interaction: Managing queries, clarifications, and real-time updates for faster approvals.
Our proven processes for regulatory submission in India ensure every detail, big or small, is accounted for, making your submission audit-ready and reducing the risk of setbacks.
Comprehensive Regulatory Compliance Consulting Services
Success goes beyond submitting forms; it’s about understanding what regulators want and providing it in the right way. Innovate Research offers regulatory compliance consulting services that put you in control:
- Device Classification (India): Ensuring all data matches regulatory expectations from the outset.
- Strategic Planning: Road-mapping your regulatory journey based on risk, product class, and market needs.
- Technical File Creation & Review: Meticulous preparation, so your documentation stands up to scrutiny.
- Dossier Submission: Managing submissions to India’s CDSCO, plus harmonizing paperwork for USFDA, EMA, and other agencies.
- Post-Market Surveillance & Reporting: Ongoing support to meet evolving safety and compliance requirements.
Our medical device regulatory services adapt to simple and complex needs, helping you avoid common pitfalls and make smarter decisions for long-term success.
Why Partner with Innovate Research for Regulatory Support?
Working with Innovate Research means access to the best regulatory support for medical device companies:
- Global and Local Knowledge: Deep expertise in both India’s frameworks (CDSCO, Medical Device Rules) and global regulations (FDA, EMA, IMDRF).
- Strong Regulatory Relationships: Trusted connections with key agencies, enhancing transparency and communication.
- Proven Acceleration: A track record in reducing time-to-market for startups and multinationals alike.
- Cross-Sector Competence: Wide-ranging experience spanning medical devices, pharmaceuticals, nutraceuticals, and diagnostics.
- Adaptive, Technology-Driven Solutions: Leveraging digital tools for submission tracking, version control, and regulatory intelligence.
We don’t just offer regulatory support for medical devices; we build lasting partnerships based on integrity, speed, and scientific precision.
FAQs About Regulatory Submissions in India
Medical device regulatory compliance means meeting all national and international requirements for safety, performance, and documentation to achieve market approval and maintain ongoing surveillance.
Innovate Research combines in-depth knowledge of Indian regulations with structured document preparation and digital submissions, ensuring complete, timely, and responsive filings for every device.
Key documents include a Device Master File, technical specifications, safety data, clinical evidence, labeling information, and detailed dossiers as required by CDSCO and international authorities.
Yes. Our services include ongoing compliance management, post-market surveillance, safety reporting, and documentation updates to help you stay audit-ready.
Absolutely. Innovate Research provides regulatory support for medical, devices in India and worldwide, harmonizing with both local and international standards to maximize market access.