We provide complete support for Pharma Regulatory services with our expert Pharma Regulatory Affairs consulting services for global markets, particularly in the EU and US.
Zenovel has a highly experienced team of experts who have a complete understanding of the complete requirements of Pharma Regulatory affairs throughout the drug life cycle. Our experts have experience in directly corresponding with Pharma regulatory authorities for various segments.
With our extensive experience on Clinical Trial /Research Process flow, Zenovel has complete and comprehensive know-how on the Clinical Research Regulatory process for pre-approval application. We have been supporting many clients globally with Clinical Regulatory Affairs services for taking approval from local regulatory agencies.
With continuous support from pre-submission, during submission and post-submission, we make it extremely convenient for our clients for smooth and speedy approval of their products and reach out to their commercial goal in cost-effective ways.
Regulatory Services:
Regulatory support during drug life cycle:
- Regulatory Intelligence services and decoding dossier requirements
- Pre submission assessment and compilation
- Registration and application of NDA, ANDA, IMP and Biosimilar
- Assistance during regulatory review process
- Post submission support services
- Relaunch of product in new market
Standalone supports like,
- Registration of facilities for global identification,
- Communication with Regulatory agencies
- Selection of dissolution media for best in-vitro results,
- Assessment of Dissolution profile,
- Review of Drug master file,
- Stability data evaluation as per regulatory requirement,
- Pilot to Scale up batch design,
- Module 1 preparation,
- API filling
- Transformation from paper data to eCTD format,
- Selection and procurement of RLD,
- Medical writing services like protocol, CRF etc
- Conducting BABE study
Strategy making for Pharma Regulatory Affairs to meet commercial goals in the shortest possible timeline.