Provide comprehensive Regulatory services across the spectrum of global product development, registration and commercialization. Specializes in Dossier strategy, Dossier Gap Analysis, Dossier Compilation, Regulatory Content Authoring, Validation and final submission of various global new product authorization applications(Investigational New Drug - IND Application both for Pharmaceutical and Biological products ,Clinical Trial Application (CTA) ,Generic Application ,New Drug Application - NDA Application among others. Assist organizations right from decoding Regulatory pathways to providing regional Regulatory intelligence to successfully defining strategies for various health authority submissions and market approvals Provide end-to-end labeling services and software support for global and regional labeling management, professional assistance in drafting Investigational Brochure (IB), Developmental Core Data Sheet, and Developmental Core Safety Information Assist in Pack Management CoE provides innovative, cost effective, creative graphic design & artwork services to support new product launches and brand re-designs for global pharmaceutical and consumer healthcare companies Assist in medical regulatory writing (SPC,Leaflets) Clinical trial services like Protocol writing and expert review,Regulatory CSR writing and review,Investigator Brochure (IB) development and expert review Informed Consent Form (ICF) preparation and expert review,Preparation of IND and application supporting documents