Market Access Management
Select the right market and the right partners; through our network we will direct you to a variety of potential and trusted partners will play a role in managing the communication and guiding you during the agreement negotiation process.
Regulatory Assistance
Overcoming complex regulations and access hurdles, shorten time to market and accelerated registration through our regulatory expertise all over the region will provide excellence in the process effectively and efficiently.
Pharmacovigilance activities Management
MENA-GATE Group can provide our specialised support to Marketing Authorisation Holders (MAHs) to meet the Good Pharmacovigilance Practice (GVP) Guidelines through various activities including:
- Proper maintenance of the Pharmacovigilance System Master File
(PSMF). - Taking over the Qualified Person for Pharmacovigilance (QPPV) and
QPPV deputy roles. - Ensuring a functioning Pharmacovigilance system is in place for both business hours and out of hours collection.
- Taking care of the data collection from various sources.
- Compilation and regulatory submission of Risk Management Plans (RMPs) and subsequent implementation of applicable Risk Minimization
Measures (RMMs). - Training personnel on Pharmacovigilance.
- Providing our advice and support to MAHs while preparing for Pharmacovigilance Inspections and in the subsequent creation of necessary Corrective and Preventive Actions and their effective implementation.
- Preparing and submitting Periodic Safety Update Reports (PSURs).
Digital Solutions
Digital solutions are no longer optional, companies must embed a digital-first approach into every facet of the business MENA-GATE Group helps the partners to grow in today’s hypercompetitive marketplace.
MENA-GATE Group is ready to provide you with:
- ERP.
- CRM, CLM.
- eCTD.
Pharmacovigilance Software solution (PV-Pedia). - E-learning.
- Online consultation solution for healthcare professionals.
- Hospital management.
- Health Insurance Management.
- Waste management.
- Webinars.
OUR SERVICES?
