Our New Drug Approval Services

We offer end-to-end support for new drug approvals in India, including:

• Regulatory Strategy Development: Tailored guidance to optimize approval timelines and ensure compliance.
• Dossier Preparation and Submission: Assistance with preparing the Common Technical Document (CTD) or eCTD for submission to CDSCO.
• Clinical Trial Support: Guidance on protocol design, regulatory submissions, and post-trial reporting as per the New Drugs and Clinical Trials Rules.
• Regulatory Liaison: Direct communication with CDSCO for expedited reviews, clarifications, and updates.
• Post-Approval Compliance: Support with labelling, variations, and pharmacovigilance requirements post-market launch.

Subsequent New Drug Approval:

The approval of Subsequent New Drugs (SNDs) is a critical regulatory step for modified or derivative versions of already approved drugs. At Elevatia Solutions, we offer comprehensive support to streamline the approval process and help you navigate the complexities of the regulatory framework.

Under the New Drugs and Clinical Trials Rules, 2019, a drug is classified as a Subsequent New Drug (SND) when it involves changes such as new dosage forms, new routes of administration, combination drugs, or modifications in indications. These changes require additional regulatory submissions and approval from the Central Drugs Standard Control Organization (CDSCO) before commercialization.

Drug Import and Registration in India

The Indian pharmaceutical market offers immense opportunities, but entering it requires strict compliance with regulatory requirements for drug import and registration. At Elevatia solutions, we specialize in providing end-to-end support for companies looking to register and import drugs into India, ensuring a seamless process aligned with the regulatory framework governed by the Central Drugs Standard Control Organization (CDSCO).

Regulatory Framework

The import and registration of drugs in India are regulated under the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945. Before any drug can be imported into India, it must receive a Registration Certificate (Form 41) and an Import License (Form 10) issued by CDSCO.

Our Drug Import and Registration Services

We offer comprehensive support to ensure compliance with Indian regulatory requirements, including:

• Regulatory Feasibility Assessment: Evaluating your product’s regulatory requirements for successful entry into the Indian market.
• Dossier Preparation and Submission: Assisting with the preparation of the drug master file (DMF) and ensuring all required documentation is in compliance with CDSCO guidelines.
• Registration Certificate Application (Form 41): Managing the application process for the approval of drugs, including finished formulations, bulk drugs, and biologics.
• Import License Application (Form 10): Facilitating the import license process to enable the shipment of approved drugs into India.
• Regulatory Liaison: Acting as your authorized agent in India for efficient communication and coordination with CDSCO.

Clinical Trial Approval in India

Clinical trials are an essential step in the development of new drugs and therapies, ensuring their safety and efficacy before they are brought to market. In India, the clinical trial approval process is governed by the Central Drugs Standard Control Organization (CDSCO) under the New Drugs and Clinical Trials Rules, 2019. At Elevatia Solutions, we offer comprehensive support to help you navigate the regulatory landscape and secure timely approvals for your clinical trials.

Regulatory Framework

Clinical trial approvals in India require compliance with the Good Clinical Practice (GCP) Guidelines and the Ethical Guidelines for Biomedical Research on Human Participants issued by the Indian Council of Medical Research (ICMR). Sponsors must obtain approvals from:

• The Central Licensing Authority (CLA) through the CDSCO.
• An Institutional Ethics Committee (IEC) overseeing the trial.

Our Clinical Trial Approval Services

We provide end-to-end assistance for clinical trial approval, ensuring compliance and timely execution. Our services include:

• Regulatory Strategy Development: Designing a roadmap tailored to your clinical trial’s objectives and regulatory requirements.
• Dossier Preparation and Submission: Preparing and submitting the Clinical Trial Application (CTA) in the prescribed format.
• Protocol Development: Crafting trial protocols that align with GCP and CDSCO guidelines.
• Ethics Committee Approvals: Assisting with documentation and applications for IEC approvals.
• Regulatory Liaison: Facilitating communication with CDSCO and addressing any queries or concerns during the review process.
• Post-Approval Compliance: Supporting adherence to regulatory requirements such as trial monitoring, periodic updates, and safety reporting.