Regulatory Services
Preparation of chemistry, manufacturing, and controls (CMC) documentation for drug
substances and finished formulations Preparation of Clinical and Non Clinical (Overviews
& Summaries), Study Reports, Protocols and others To Prepare, Compile, & Submit
DMFs & Dossiers (Investigational Medical Product Dossier (IMPD) / Investigational
new drug (IND) applications, NDAs and Generics for various countries Preparation
and Submission of Annual Reports, Variation Applications, Renewal Application, Amendments
and Supplements Briefing Documents Response to queries from Regulatory Authorities
Life Cycle Management
Development of patent non infringing / stable and bio-equivalent products.
At-a-glance: Pre-submission Service:
- Regulatory Affairs support (CTAs, IMPDs, INDs, NDAs, MAA, global registration submission)
- CMC Authorship (CTAs, IMPDs, INDs, NDAs, MAA, global registration submissions)
- Regulatory Affairs and CMC strategic guidance
- Publishing support – all submission types and format, and reports
- Regulatory Intelligence
- DMFs
- EDQM Certificate of Suitability applications
- Stability data assessments
At-a-glance: The Post-Submission Service:
- Regulatory Affairs support across the lifecycle (variations, renewals, annual reports)
- CMC Authorship across the lifecycle (variations, renewals, annual reports)
- Regulatory Affairs and CMC strategic guidance
- Publishing support – all submission types and format, and reports
- Labeling
- Regulatory Intelligence
- Site rationalization regulatory support
- Stability Data Assessments
- CTD Conversions (content and format)
-
Clinical Trial support for Clinical Development, Bioavailability & Bioequivalence
studies activity
Countries we serve
- Abbreviated New Drug Application (ANDA) - US
- European Union Registration - EU
- Agencia Nationale Vigilenca de Sanitaria (ANVISA) - Brazil
- Medicines & Healthcare Products Regulatory Agency (MHRA) - UK
- Therapeutic Goods Administration (TGA) - Australia
- Medicines Control Council (MCC) - South Africa
- Commonwealth of Independent States (CIS) Registration
- Registration in all other Regions across the globe
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