. Legal Authorized Representative & License Holder: MRG acts as the license holder on behalf
of the manufacturer, ensuring regulatory compliance and effective management of
pharmaceutical products.
. Product Registrations:
Human Pharmaceuticals: MRG manages the entire registration process for human pharmaceuticals, from initial submission to final approval.
. Technical Document Expertise:
Gap Analysis and Validation: MRG performs comprehensive gap analysis and validation of technical documents to ensure regulatory compliance. Scientific and Pharmacoeconomic Files: Preparation and submission of scientific and pharmacoeconomic files are conducted to meet regulatory requirements.
. Submission Management:
CTD/eCTD Compilation: MRG handle the compilation of Common Technical Document (CTD) and electronic Common Technical Document (eCTD) for both local and export submissions. Labeling and Artwork Services:
Our services include the development and approval of
labeling and artwork to meet regulatory standards.- Variation Management: MRG manages all types of regulatory variations efficiently.
. File Compilation and Submission:
– Analysis, Stability Study, and Bioequivalence Files: MRG compiles and submit analysis, stability study, and bioequivalence files, and provide
continuous follow-up until approval.
.Pharmacovigilance Services:
– The Egyptian Drug Authority (EDA)- (EPVC) Registered Provider: MRG offer pharmacovigilance services as a registered provider with The
Egyptian Drug Authority (EDA)- (EPVC).
– Comprehensive PV Activities: Our services include full pharmacovigilance activities such as the preparation of essential documents
(PSMF, RMP, ICSRs, PBRER).
. Product Advertising Services:
MRG provide expertise in managing product advertising, ensuring compliance with regulatory guidelines.
. Pharmaceuticals General Consultations:
Offering general consultations on pharmaceuticals to support regulatory strategy and compliance.