www.meherpharma.

com
OUR SERVICES
REGULATORY • CDSCO Application Assistance
SERVICES • CTD Dossier/ DMF Compilation
• Analytical Method Validation (AMV)
• Comparative Dissolution Profile (CDP)
• Bio-Waiver Report Compilation
• Experts Review of Clinical for CTD Dossier
• Experts Review of Preclinical for CTD Dossier
PHARMACOVIGILANCE • End to end processing & submission of Independent Case Study
Report (ICSR)
SERVICES
• Aggregate Report Writing & Review
(PSUR/PBRER/PADER/DSUR)

• Preparing PSUR for submission to CDSCO

• Risk Management Planning (RMP)

• Medical Literature Monitoring (MLM)

• Pharmacovigilance System Master File (PSMF)

• SOP of Pharmacovigilance

• Signal Detection, Assessment & Management

• Audit & Inspection Support

• Evolving & Implementing CAPA

CLINICAL TRIAL • Clinical Trial Outsourcing of Herbals as Per AYUSH Guideline

STUDY for domestic purpose and for export registration
• Regulatory Support and Outsourcing as per requirement for
domestic submission and for export registration in case of
medicine.
BIOEQUIVALENCE • Regulatory Support and Outsourcing as per requirement for
STUDY domestic submission and for export registration in case of
medicine.
PUBLISHED • You can buy published safety and efficacy article for regulatory
ARTICLE submission.
• Case Study for PSUR compilation
• Preclinical and Clinical part of dossier compilation
SKILLS TRAINING • Diploma in Product Management/ Pharmacovigilance
For students, working • Diploma in Export Management/ Regulatory Management
professionals and for • Diploma in Hospital/Community Pharmacy
company executives. • Diploma in Pharmacology/ Business Excellence

Free consultation as how to establish export house