In a bid to expand its business globally CosmoTrace, a leading Consulting organization that offers Serialization & Traceability strategy consulting, has set up a new office in Sharjah Media City (Shams), UAE to provide Traceability & Serialization consulting services in the Middle East to the Pharma and other highly regulated industries.
I believe expanding our operations in the UAE would be a first step for us in catering to the needs of pharmaceutical companies in the Middle east. Our new office in the UAE will be instrumental in meeting the demands of the growing and evolving serialization & traceability requirements in the Middle east, said Zeeshan Ahmed, Founder & CEO, CosmoTrace.
We at CosmoTrace are committed to providing Pharma companies with a full suite of Serialization services and we are confident that our extensive knowledge and experience working with the clients in Europe & the USA would bring both speed as well as optimization to the pharmaceutical companies in the GCC region as we are well aware of the challenges that arise in the implementation of serialization, he added.
Traceability & serialization requirements are being mandated across the MENA region to combat the growing problem of counterfeit medicines. There has been good progress made by Saudi Arabia, UAE and Bahrain in relation to the Serialization & counterfeit efforts so far. Saudi Arabia & Bahrain are already LIVE and UAE compliance deadline is the 13th of Dec 2022. The remaining countries in the region are expected to follow suit and introduce the serialization requirements sooner or later.
Failing to achieve compliance with the upcoming regulations can put Pharma companies at risk for non-compliance and it could lead to penalties such as fines or getting barred from product launches which can have significant business and financial implications.
Therefore, pharmaceutical companies selling or planning to sell in this region need to clearly understand the regulatory requirements and implement the necessary changes to their product labeling and internal processes. CosmoTrace with its experience can help pharmaceutical companies in this region to meet the local as well as global compliance requirements.
If you’re a Pharma MAH, Contract Manufacturer, Wholesaler or a 3 party logistics provider based in the Middle East and looking for expert skills for your Pharma Traceability & Serialization projects, then we’d love to speak with you.
Our Serialization services offering for the middle east will include:
End to End Serialization Project Management & Technical consulting services for all the level 4 software providers such as Tracelink, Rfxcel, SAP, Antares Vision & Arvato to name a few.
New business partner onboarding (CMO, MAH, Distributor)
Validation of connection with business partners and local authorities
Uploading and updating master data & reporting to the authorities such as BrandSync, Tatmeen, NHRA, SFDA.
Country Compliance Support – EUFMD, DSCSA, Russia, Gulf and near east and Brazil
Serialization System Management and Health Check
Serialization project managed services
Serialization software system Testing and Validation
Serialization software Vendor Selection Assessment
Serialization process SOPs and documentations
We provide serialization consulting, implementation & integration services to help our clients with managing the end-to-end serialization projects and preparing them for the existing and upcoming regulations.
We are well versed with the compliance regulations for various markets and can help you with implementing the serialization project to meet the deadlines.
As Serialization Consulting & Implementation Experts, our focus is on delivering the absolute best serialization support by offering long-term serialization strategies and providing forward-thinking industry solutions
Companies of varying sizes and segments have selected CosmoTrace as their serialization consulting and implementation partner.