Our services

Everything your products need, from development to market

Pharmacovigilance, clinical research, software solutions, regulatory affairs and training, delivered by one team that knows the Egyptian market better than anyone. Choose a service to see what it covers.

Pharmacovigilance Clinical Research Software Solutions CTD and Regulatory Services Training Project Management

Pharmacovigilance

Safety systems that hold up under any inspection, run by the team many consider the best pharmacovigilance service provider in Egypt.

Pharmacovigilance Outsourcing Full or functional outsourcing of your PV system, from case processing and signal management to safety documents and authority inspections.Pharmacovigilance Audit Independent GVP audits of your system, affiliates and vendors, with a clear plan to close every gap.PV and ADR Reporting Adverse event monitoring and reporting throughout your clinical trials and after launch.PV Literature Screening More than 2,000 active ingredients screened every month across 60 international and local sources.

Clinical Research

Local and international studies from Phase I to Phase IV, managed by a CRO that sponsors in Egypt trust to deliver on time and on budget.

Clinical Studies Management End-to-end trial management, from feasibility and approvals to the final clinical study report.Protocol Development Scientifically sound protocols and informed consent documents, ready for ethics and authority review.Site Selection and Management The right investigators and sites, supported from initiation to close-out.Clinical Monitoring Risk-based monitoring that protects participants and the integrity of your data.Data Management and Biostatistics Clean, traceable data and sound statistical analysis, captured on Insight EDC.Medical Writing Protocols, clinical study reports, clinical evaluation reports and publications.

Software Solutions

Software and automation made specifically for the pharma industry, led by Vigipx, Egypt’s number one safety database.

Vigipx Safety Database The ICH E2B (R3) safety database most pharmacovigilance teams in Egypt rely on.Insight Academy Online pharmacovigilance and regulatory courses and videos for your whole team.Insight EDC Electronic data capture for clinical studies.Dossier Hub Registration dossiers in CTD and eCTD format, built and managed in one place.

CTD and Regulatory Services

Registration files that are right the first time, and a team that keeps your products compliant for their whole life on the market.

CTD, eCTD and Regulatory Services Regulatory strategy, CTD and eCTD dossiers, product registration, variations and lifecycle management.

Training

Practical training from people who do this work every day, in the classroom and online.

Pharmacovigilance Training Customised programmes for individuals and PV teams, from first principles to advanced practice.CTD Training Course A complete course on preparing CTD and eCTD dossiers for registration in Egypt and abroad.Insight Academy Online courses and videos, developed and reviewed by former members of the Egyptian Drug Authority and WHO experts.

Project Management

Every engagement is run as a project, with a named project manager, a clear plan and regular progress reports, so it is delivered on time, within budget and to the agreed quality.

Start Your Project A guided project brief covering your objectives, scope, timeline, budget, quality and risks. A project manager reviews it and comes back with a proposal.