CDSCO Licensing

Navigating Regulatory Pathways with Expertise

Obtaining the necessary licences from the Central Drugs Standard Control Organization (CDSCO) is a critical step for medical device and diagnostics companies looking to enter and operate in the Indian market. IQzyme offers expert guidance and comprehensive services to simplify the CDSCO licensing process, ensuring compliance and facilitating timely market access for your products.

Our CDSCO Licensing Services

Regulatory Strategy Development

Strategic Planning: Develop a tailored regulatory strategy that aligns with your business objectives and product requirements.

Pathway Identification: Identify the appropriate regulatory pathway for your product, whether it's a medical device, in vitro diagnostic (IVD), or combination product.

Pre-Submission Consultation

Regulatory Consultation: Provide expert advice on regulatory requirements, classification, and documentation needed for CDSCO submissions.

Gap Analysis: Conduct a thorough gap analysis to identify any missing or insufficient information in your existing documentation.

Documentation and Submission Preparation

Dossier Compilation: Prepare and compile all necessary documents, including technical files, clinical evaluation reports, and quality management system documentation.

Submission Filing: Handle the preparation and submission of applications to CDSCO, ensuring compliance with all regulatory requirements.

Clinical Evaluation and Testing

Clinical Trials Management: Assist with the planning, execution, and documentation of clinical trials or studies required for product approval.

Performance Testing: Coordinate performance testing and validation of your product to meet CDSCO standards.

Post-Submission Support and Liaison

Regulatory Liaison: Act as a liaison between your company and CDSCO, addressing any queries or requests for additional information.

Follow-Up and Compliance: Monitor the progress of your application, ensuring timely responses and compliance with any additional requirements.

Post-Market Surveillance and Compliance

Ongoing Compliance: Provide support for post-market surveillance and reporting obligations, ensuring continued compliance with CDSCO regulations.

License Renewals: Assist with the renewal of CDSCO licences and modifications to existing approvals as needed.

Why Choose IQzyme for CDSCO Licensing?

Regulatory Expertise: Our team has extensive experience in navigating CDSCO regulations and a deep understanding of the Indian regulatory landscape.

Customized Solutions: We offer personalized services tailored to your specific product and business needs, ensuring a smooth and efficient licensing process.

Comprehensive Support: From initial consultation to post-market compliance, we provide end-to-end support to help you achieve your regulatory goals.

Commitment to Success: We are dedicated to helping you secure the necessary approvals and bring your products to market with confidence.

Achieve Regulatory Success with IQzyme

Streamline your CDSCO licensing process and ensure compliance with IQzyme’s expert guidance and support. Contact us today to learn how we can assist you in obtaining the necessary licences and gaining access to the Indian market.