01
Product registration
Support assembling and reviewing the information typically required for pharmaceutical registration procedures in the target market.
Loading page…
Industry focus
Practical assistance with product registration planning, dossier organisation, CTD/eCTD-oriented file structure, submissions, variations, renewals, labelling review and regulatory intelligence—without overstating licensed manufacturing or authority functions.
Category perspective
MEPA supports pharmaceutical manufacturers, marketing authorisation holders and distributors with regulatory planning and file organisation for UAE and GCC markets. The work is consultancy support for documentation, classification questions, submissions and maintenance. It does not replace a manufacturing licence, marketing authorisation or any activity that may only be performed by a licensed establishment.
01
Support assembling and reviewing the information typically required for pharmaceutical registration procedures in the target market.
02
Early discussion of classification, intended use, strengths or presentations, and the implications for filing sequence.
03
Organisation of administrative and technical documents into a coherent working dossier for internal review.
04
Help structuring information in a CTD-oriented manner where that format is relevant. MEPA does not claim to operate as a software vendor or gateway provider.
05
Preparation support, consistency checks and query handling during the application process.
06
Documentation support for post-approval changes and renewal cycles.
07
Review of prescribing information, outer packaging and related artwork against the current file.
08
Maintenance of the working regulatory file after authorisation, including change tracking.
09
Monitoring of publicly available developments that may affect registered products or planned filings.
Questions, answered
No. MEPA is a regulatory affairs consultancy. Manufacturing, importation, wholesale and pharmacy activities require the appropriate licences held by other parties.
No. Authority review and the resulting decision sit with the competent body. Consultancy support improves file quality and process management; it cannot assure an outcome.
Consultation, strategy, procedures and outsourced regulatory support throughout the product lifecycle.
Product, label and formula validation, technical translation, artwork and registration support from launch through lifecycle changes.
Quality systems, GxP readiness, audits and certification support for regulated products and operations.
Entity setup, healthcare licensing, pharmaceutical facility renewals and licensed pharmacist hiring support.
Pharmacovigilance services to support product safety processes, documentation and ongoing coordination.
Start a conversation