Skills

• Preparation and filing of Registration dossiers for submission to various regulatory agencies all over the world (including eCTD, CTD format & ACTD Format).
• Drug Master File (DMF) compilation for open and closed part.
• Preclinical and clinical overviews writing through literature search / published studies / articles from journals from different sources.
• Expert reports on Quality , Pre-clinical and Clinical
• Orphan Drug Application Preparation and Submission.
• Prepare summary of product characteristic (SmPC), Pack Insert, Product rationale.
• Assistance in Response to queries for submission to the Regulatory Agencies.
• Total development of product from lab scale to pilot plant scale to actual production scale for Drug Substance and Drug product.
• Prepare summary of product characteristic (SmPC), Pack Insert, Product rationale.
• Periodic Safety Update Report (PSUR) preparation.
• Provide analytical support in analytical method development / validation, Routine analyses of products by HPLC/GC/MS etc.
• Complete stability programme management service is provided as per ICH guidelines / special requirements in a cGMP and GLP compliant environment.
• Monitoring and liaisoning with the CRO’s for Clinical and BE Studies.
• Preparation of Site Master file
• Compilation of dossier as per latest country specific guidelines

Time and Spatial Flexiblity

ALL OVER IN INDIA

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