New Product Authorizations
Presubmission technical data reviews Gap Analysis Regulatory Content authoring Dossier compilation, validation and final submission of new product authorization applications for global filing Review Gap Analysis & Remediation Advisory Dossier Authoring - CMC Sections & Summaries Biowaiver Justifications SmPC/PIL/PI authoring/Reviews Agency Query responses
Post Approval Life Cycle Management
Response to agency queries/notices on marketed products Variations Manufacturing Site Transfers Risk Assessments Compliance and renewals
Pharmacovigilance Services
Drug safety services Collates, processes and compiles relevant safety information from all sources, including individual cases, published literature and clinical studies
Product Labeling
Build a compliant label for products; keep it updated all the time the product is in market, suggest changes in line with global updates SmPC/PIL/PI Authoring Tracking and implementation of labeling Changes Agency query responses on Labelling
