Contact us for a regulatory consultation
We specialize in regulatory affairs, pharmacovigilance, medical writing, and pharmaceutical logistics and storage – delivering strategic solutions that accelerate market access.
Pharma Solutions is a Dubai-based consultancy dedicated to guiding pharmaceutical, medical device, and healthcare companies through the complexities of regulatory compliance across the UAE, Egypt and GCC.
Meet our clients and partners
Collaboration with us
leads to faster growth
Our Products at Pharma Solutions
01
Convential medicines
02
Biological products
03
MEDICAL DEVICES
04
FOOD SUPPLEMENTS
05
HERBAL MEDICINE
Regulatory Affairs
We guide clients through every stage of regulatory planning, submission, and lifecycle management ensuring full compliance with GCC authority requirements.
Regulatory strategy development and consulting
Drug registration, renewal, and product variations
Site and manufacturer registration
MAH (Marketing Authorization Holder) registration
CTD/ eCTD Dossier optimization, compilation, and submission aligned with GCC standards.
Pharmacovigilance
We design and manage robust PV systems that meet GCC safety standards and ensure continuous compliance.
QPPV & LSRP approvals
PV system setup, and training
PSMF, RMP, and SOPs documentation
Ongoing compliance and authority reporting
Medical Writing & Translation
We deliver clear and compliant translation that supports regulatory success and patient safety.
Dossier content and pharmacology profiles
SmPC and PIL creation and translation (English to Arabic)
Medical writing and translation for regulatory submissions.
Pharmaceutical Logistics & Storage
We provide secure GSP, GDP compliant logistics and storage solutions for pharmaceutical products across the GCC.