Overview
Maven provides support for various types of biological medicinal products that include but are not limited to the following:
- Vaccines
- Recombinant therapeutic proteins and Monoclonal antibodies
- Blood and Sera products
- Cellular and Gene therapy product
Expertise
- Regulatory strategies and route maps for development & registration of innovator products
- Expert advice on mitigation plans for product developmental issues/ submission risks
- Monitoring of developmental programs on a periodic basis and assisting clients with Regulatory support
- Assessment of data generated and Regulatory gap assessment to identify anticipated submission risks
- Complete support in pre-submission interactions with Regulatory agencies
- Support in Orphan Drug Designation applications
- Evaluation for expedited programs and support in submissions to US/EU agencies
- Submission services for innovations & proprietary technologies, including Master File services
- Guidance on the designation of specifications for substances, products, and controls
- Consulting in defining limits for genotoxic and elemental impurities
Advantages
- Cost-effective
- End-to-end Regulatory consultation
- Qualified team of experts across Pharmaceuticals, Biologics, Biosimilars & Vaccines
- Expert support for region-specific Regulatory complexities
- Direct interactions with Health Authorities (HAs)
- Structured approach ensuring quick product launch or market access
