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High-impact marketing services

Pharma Solutions LLC delivers a full spectrum of regulatory, safety, and operational support tailored to the GCC pharmaceutical and healthcare sectors. Drawing on over 15 years of regional expertise and global best practices, we offer strategic, compliant, and client-focused services across four core domains

Regulatory Affairs

We guide clients through every stage of regulatory planning, submission, and lifecycle management ensuring full compliance with GCC authority requirements.

Key services include:

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.