Benefit from our expertise in preparing Common Technical Document (CTD) and electronic Common Technical Document (eCTD) submissions, ensuring your regulatory documentation aligns with international standards.

We help you comply with Indian regulatory requirements, covering new drug applications, clinical trials, global trials, import registrations, and post-approval changes. We liaise with NDAC and MDAC for efficient approvals.

Avail our specialized services for manufacturers, such as IND applications, clinical trial protocol amendments, import registrations, and licenses. Our team ensures compliance with regulatory requirements throughout the product lifecycle.

S2M provides both pre-marketing and post-marketing support, including assistance with market authorization, import licenses, test licenses, and post-approval changes. Our team streamlines the regulatory process for smooth product entry into the market.

Our global regulatory services cover dossier compilation, submission management, life cycle management, and investigational filings. We specialize in preparing reports, developing documentation, and ensuring compliance with international standards.

Rely on our pre-registration services for regulatory and quality compliance, conversion of data or dossier formats, and site due diligence.

S2M provides ongoing support, addressing variations, updating documents as per country-specific requirements, and facilitating label extensions and shelf-life extensions.

Importers benefit from our pre-marketing support, including assistance with authorized agent/registration holder support, market authorization, import licenses, test licenses, and post-marketing regulatory services.