At PRETOX CONSULTANCY (PTC), we provide comprehensive regulatory documentation and support services to help clients prepare high-quality, compliant submissions for global regulatory authorities. Our team ensures that every document reflects scientific accuracy, clarity, and alignment with current guidelines.

We support clients through the entire regulatory lifecycle — from preclinical data compilation to responses for agency queries — enabling smooth and efficient approval processes.

Our Expertise Includes:

• Non-clinical Data Overview, Summary and report review required for IND and NDA filing (CTD 2.4 and 2.6).
• Preparing the IB (Investigator’s Brochure) for drugs.
• Guidance to reply the queries received from different regulatory agencies.

With a deep understanding of regulatory frameworks and submission requirements, PTC ensures that your documentation is precise, compliant, and ready for successful global submission.