DOSSIER SERVICES & REGISTRATION ASSISTANCE

DocentPharma services have handled many regulatory submissions, in different countries, on behalf of client companies.

DocentPharma is engaged in Dossier services for highly regulated markets like USA, Canada and emerging market like Commonwealth of Independent States (CIS countries), Latin America, Asian Countries, Southeast Asia Countries and African Countries.

DocentPharma offers the following dossier services:

• Compilation, Preparation of Abbreviated New Drug Application (ANDA), Drug Master File (DMF), Supplement to Approve Application, Annual Report for USA Submission.
• Compilation, Preparation of Abbreviated New Drug Submissions (ANDS), Notifiable Change Submission (NC), Drug Identification Number
• Develop regulatory strategies for Canadian submissions to meet TPD requirements
• Dossier compilation as per Asian Common Technical Dossier (ACTD) Guidelines
• Dossiers, Renewals, Annual Updates & Variation Applications compilation for submissions in CIS, Latin America, Asian & Southeast Asia and African Countries.
• Dossiers review & Gap analysis
• Expert Reports for Quality, Pre-clinical, Clinical
• Clinical/ Non-Clinical Overview
• Responses for MOH/Authority Queries

For DocentPharma dossier services or information, please write email to us: - docent@docentpharma.com