Who we are

PharmaLex provides support across the value chain of pharmaceutical companies worldwide. 25 years of extensive experience in supporting our clients on critical projects has helped us to establish a network of local representatives in the MENA region who enable us to support our clients in the region.

Our value-driven clients solutions in MENA include:

  • Regulatory intelligence / regulatory strategy for expansion into new markets
  • Dossier gap assessment and compilation
  • CMC writing for dossier submissions
  • eCTD publishing
  • Regulatory labeling
  • Medical writing
  • Scientific advice / Scientific consulting with health authorities for establishing launch strategy
  • GxP audits to facilitate readiness for external agency audits, supplier audits, third party audits and QA / compliance consulting
  • Licensing – facilitating the import of products into the region
  • Consulting support, including language / translation services (specifically French and Arabic) as well as the provision of local expert resource in-house
  • Pharmacovigilance services – our local experts can provide support services right from setting up PSMF, training your Local Safety Officer (LSO), operational support from case processing, writing of RMP, PSUR, and signal detection for your marketed products.

Our Global Alliance Partner network, provides access to experienced local representatives who are professionals and leaders in their field of expertise and respective regions.

PharmaLex’s customer-centric approach provides better experience to our clients with dedicated resources supporting on the agreed business deliverables while ensuring timelines are met.

eCTD in the Middle East - online course
Jordan: Building the eCTD - training course

Local Contact

  • Sasi Bhushan Kuchibhotla
    Senior Director, Business Development PharmaLex MENA
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What our clients say about us

We are working with a number of large pharma companies and are looking to create a consortium of partners to collect feedback on expertise, availability and outcomes. If you would be interested in joining our consortium, please contact us on contact@pharmalex.com.

  • During the bid defense we felt that you worked well as team and are very dynamic. Preparation of such a complex dossier really needs to be done in such a way.

    Large Pharma, Germany
    VP Regulatory Affairs

  • We needed a partner to help us obtain device approval. PharmaLex have not only helped us achieve this but are now providing on-going post-marketing surveillance support. We would highly recommend them to anyone who needs specialist expertise.

    Med Device company, US
    Senior Regulatory Affairs Director

  • Our project team were very impressed with the quality of the research and the reports that you sent through. We didn’t need any convincing that your recommendations should be followed. It showed PharmaLex in a very positive light, and the Project Team are keen to work with you again.

    Leading European Specialist Pharma Company
    Head of Medical Writing and Publications

  • Thanks so much for your support over the past 30 days. Your commitment and timely communication have made working with you all a pleasant experience.

    US Biotech
    Senior QA Associate

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