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Regulatory Affairs

Navigating the Path to Compliance and Success

With extensive global experience in both pre-marketing and post-marketing regulatory strategies for a diverse array of therapeutic areas, Lambda’s Regulatory Affairs division takes the lead in delivering scientifically grounded, therapeutically tailored regulatory services. Our seasoned team of worldwide regulatory experts maintains close collaboration with pharmaceutical, biotechnology, and medical device firms. At Lambda, our team distinguishes itself through qualifications, expertise, and indispensable skills. Armed with negotiation, judgment, and effective communication skills, our professionals seamlessly engage with clients, internal teams, and regulatory authorities, ensuring a streamlined regulatory process.

Key Functions

Lambda’s Regulatory Affairs team is committed to navigating the intricacies of regulatory compliance for your products. We serve as the vital link between your innovations and the global regulatory landscape, understanding that compliance is not just a requirement but a pathway to success in the pharmaceutical and medical device industry. Entrust us with your regulatory journey, and we’ll steer it with expertise and precision.

Submission of applications to obtain approval for conducting clinical studies (BE NOC or CT NOC) from CDSCO, Delhi.


Submission of applications to secure approval for importing investigational medicinal products from overseas (T-license) via the CDSCO applicable territory zonal office (e.g., Ahmedabad/Mumbai).


Timely notification/reporting of serious adverse events/pregnancy cases reported during the study to CDSCO, Delhi.

Submission of applications to gain approval for importing/exporting narcotic drugs/psychotropic substances from the Central Bureau of Narcotics (CBN), Gwalior.


Efficiently handling the registration of clinical trials on the Clinical Trials Registry in India (CTRI).

Diverse Applications for New Drug Approvals:

Our expertise extends to handling a wide array of applications for new drugs, catering to diverse regulatory requirements:

All these applications, encompassing bioavailability-bioequivalence (BA-BE) and clinical studies, are meticulously submitted online via the SUGAM Portal, a comprehensive e-Governance solution developed by the Central Drugs Standard Control Organization (CDSCO), India.

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