AJ - Regulatory Solution
END-TO-END SOLUTIONS
SINGLE POINT RESPONSIBILITY
“Doing Things Correctly the First Time. Every Time!”
About Us
AJ Regulatory Solution is a full service regulatory affairs consultancy helping pharmaceutical companies to get their medicines to the UAE market at the fastest and easiest route. Help comes in many forms including advice, strategic planning, dossier preparation, management of submissions and all compliance issues. Recognizing that one size doesn’t fit all, we customize our services to meet client needs. We focus on providing a high level of expertise and cost-effective solutions. We have long lasting relationships with our clients. Our promise is that every client will experience complete confidence in the knowledge, abilities and reliability of our work, and will see clear benefits and results from our involvement in their projects.
Vision, Mission & Values
Vision
Our vision is to be the best pharma consultancy in GCC. We’re committed to growing our business by embracing best practices and the latest knowledge, developing strong partnerships and delivering client satisfaction. We believe in doing things correctly the first time, every time!
Mission
We combine professional regulatory affairs services with a ‘one stop solution’ for all the issues related to getting a product into market. We are driven by this ethos for forging long-lasting relationships with clients based on the work we deliver to them
What We Offer
Regulatory Consulting
MAH registration: Registering Marketing Authorization Holder Manufacturing Site Registration Pharma:Dossier compiling including and not limited to writing modules 1 and 3;
Life Cycle Management
Including but not limited to: Handling variations in products, manufacturing facility changes, addition of pack sizes, Distributor change, shelf life extension etc.
Licensing and Listing Solutions:
-> Drug store Licensing
-> Compounder licensing
-> Scientific Office setting up
-> Allotting Distributor for products
-> HAAD and DDC coding of products for insurance inclusion
Medical Affairs and Marketing support
Creating scientific presentations, brochures, drop cards, rollups Addressing queries on competitor brands Writing monographs, pamphlets and patient information leaflets Arranging marketing merchandise Conducting CME and Seminars
Pharmacovigilance
Generating SOP’s for Pharmacovigilance set up Act as Pharmacovigilance interface between company and local distributor Compiling ADR reports, Quality complaints, PSMF
What Makes Us Different
Facilitate filing of the product through our in-house distributor license
Advantage: No Time is lost in discussions to finalize an agent. During the span of registration if another agent is finalized we can ensure a smooth transition.
Regulatory Expertise
Advantage: Our team has a combined experience of 25+ yrs, there is rarely no scenario we have not faced
End to End Solution
Advantage: Distributor arrangement, Regulatory filing, Artwork designing, marketing materials, insurance coding, pharmacovigilance, Life cycle management.
Contact US
reach@ajdrugs.com
