Regulatory Services

We have our Regulatory Affairs experts with the country specific experience in different activities such as:

• Preparation and filing of Registration dossiers for submission to various regulatory agencies all over the world (including eCTD, CTD format & ACTD Format).
• Documents review before the submission to eliminate queries/ rejection.
• 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.

We also do product registration and below is the process steps:

• Dossier compilation
• Dossier preparation
• Dossier Review
• Application Drafting
• Handling MOH queries
• Draft query reply
• Advice on Registration Management
• Pack insert / PIL drafting
• SMPC Drafting
• Document (technical) preparation