Regulatory
Drug Registration and Regulatory Affairs
We prepare, review and submit registration dossiers for medicines and health products in the UAE and abroad, including US FDA registration, and follow each file until a decision is made.
80+ countriesthrough the Regulanet network
The problem
Registration files get rejected or delayed for gaps that could have been caught before submission.
What we do
We prepare, review and submit registration dossiers for medicines and health products in the UAE and abroad, including US FDA registration, and follow each file until a decision is made.
Terms and conditions apply. Read the terms
Who it is for
Manufacturers and marketing-authorisation holders entering the UAE, the GCC or the US market.
What you receive
- Gap analysis of your existing dossier.
- CTD dossier preparation and formatting.
- UAE registration submissions and follow-up.
- US FDA establishment and product registration support.
- Access to a regulatory network covering more than 80 countries through Regulanet.
- Responses to regulator questions.
How we deliver it
- Review of the product and the target markets.
- Gap analysis and a written plan.
- Dossier preparation and internal review.
- Submission to the authority.
- Follow-up and responses to queries.
- Decision and post-approval support.
The value to youA complete file on first submission, and one team following it to a decision.
Related services
Bioequivalence and Clinical Research (CRO)We plan and run bioequivalence and pharmacokinetic studies for pharmaceutical companies, from protocol design and ethics approval to clinical conduct, bioanalysis, statistics and the final study report.Bioanalytical and Drug Analysis LaboratoryLC-MS/MS method development, validation and sample analysis for drugs, metabolites and residues in biological, food, plant and environmental samples, with results issued in a signed certificate of analysis.Drug Formulation DevelopmentPre-formulation studies, prototype formulations and analytical support for generic and new products, designed from the start to match the reference product and pass registration.
Tell us about your product or your samples
We reply with the right method, a timeline and a written quotation. A non-disclosure agreement comes first if you need one.