Our Services Include
At Vaayath, we provide end-to-end regulatory consulting for new drug approvals, helping pharmaceutical companies achieve timely market authorization while ensuring compliance with the Drugs and Cosmetics Act, New Drugs and Clinical Trials Rules, 2019, and applicable CDSCO guidelines. Whether you are introducing an innovative product, a fixed-dose combination, a new indication, a modified dosage form or a biological product, our regulatory experts support you throughout the approval journey.
- Regulatory pathway assessment and product classification
- Gap analysis of available technical and regulatory data
- Preparation and review of Common Technical Document (CTD/eCTD) dossiers
- Preparation of application forms and regulatory documentation
- Scientific and regulatory justification for new drug applications
- Preparation of responses to CDSCO deficiency letters and technical queries
- Coordination and liaison with CDSCO during the review process
- Guidance on Subject Expert Committee (SEC) presentations and requirements
- Post-approval regulatory support, including variations and lifecycle management
Our Approach
Every project follows a structured methodology to ensure efficiency and regulatory compliance.
Regulatory Assessment
Evaluate the product, applicable regulations and approval pathway.
Regulatory Strategy
Develop a tailored regulatory roadmap based on product characteristics and business objectives.
Documentation & Dossier Preparation
Prepare technically sound dossiers and supporting documentation in accordance with CDSCO requirements.
Submission & Authority Coordination
Manage regulatory submissions, authority interactions and timely responses to queries.
Approval & Lifecycle Support
Provide continued support for post-approval variations, renewals and ongoing regulatory compliance.
Who this is for
Products We Support
Our expertise covers a wide range of products, including:
Why This Service Matters
An effective regulatory strategy can significantly reduce approval timelines, minimize regulatory deficiencies and improve the likelihood of successful market authorization. Our team works proactively to identify potential regulatory challenges, develop practical solutions and facilitate smooth interactions with regulatory authorities.
Why Choose Vaayath?
- 20+ years of regulatory expertise
- Extensive experience with CDSCO regulatory procedures
- Comprehensive technical dossier preparation and review
- Dedicated regulatory consultants for every project
- Practical and commercially focused regulatory strategies
- End-to-end support from concept to commercialization