Oxzan GXP Solutions Dubai

GLOBAL COMPLIANCE

Regulatory Submissions & Compliance Services

Pharmaceutical and Non-Pharmaceutical Products | UAE | GCC | FDA | EU

At Oxzan GxP Solutions, we provide comprehensive regulatory submission and compliance support for both pharmaceutical and non-pharmaceutical healthcare products, enabling safe, compliant, and timely market access across the UAE, GCC, United States, and European Union. Our services are structured to meet the regulatory expectations of MOHAP, GCC authorities, US FDA, EU EMA, and internationally harmonized WHO and ICH guidelines.

MEDICINAL PRODUCTS

Pharmaceutical Regulatory Services

Pharmaceutical products are regulated to ensure quality, safety, and efficacy throughout their lifecycle, from development to post-marketing surveillance. Oxzan GxP Solutions supports regulatory submissions for innovator, generic, biosimilar, and specialty medicinal products, in line with MOHAP, GCC, FDA, and EMA requirements.

Submission Support

Marketing Authorization Applications (MAA)
CTD and eCTD dossier preparation
Quality (CMC) documentation
Stability and validation data review

Regulatory Alignment

Clinical and non-clinical summaries
Pharmacovigilance support
ICH guidelines compliance
WHO Technical Report Series

All submissions are prepared in accordance with ICH guidelines, WHO Technical Report Series, EU GMP, and FDA regulations, ensuring global alignment and audit readiness.

We also provide full post-approval lifecycle management, including variations, renewals, change control submissions, and regulatory responses, supporting continuous compliance and uninterrupted product supply.

HEALTHCARE PRODUCTS

Non-Pharmaceutical Regulatory Services

Non-pharmaceutical healthcare products are regulated under distinct but equally rigorous frameworks to ensure safety, performance, and consumer protection. Oxzan GxP Solutions supports regulatory submissions and compliance for medical devices, in-vitro diagnostics (IVDs), cosmetics, food supplements, health supplements, disinfectants, and medical equipment, in line with MOHAP, GCC, FDA, and EU requirements.

Regulatory Support Services

Product classification
Technical file preparation
Labeling and claims compliance
Risk assessments
Performance data review
Post-market regulatory maintenance

Standards & Compliance

We align submissions with applicable standards such as:

ISO Standards
WHO Guidance
EU MDR/IVDR
FDA 21 CFR
GCC Conformity Requirements

Ensuring regulatory clarity and faster approvals.

STRATEGIC APPROACH

Integrated Regulatory Strategy

Whether pharmaceutical or non-pharmaceutical, successful regulatory approval depends on a clear regulatory strategy, accurate documentation, and strong compliance systems. Oxzan GxP Solutions integrates regulatory intelligence, GxP compliance, and authority expectations into a unified submission approach, minimizing review delays and regulatory risk.

By aligning MOHAP submissions with FDA and EMA reference authority standards, we support reliance pathways, improve authority confidence, and facilitate multi-regional market access.

OUR COMMITMENT

Our Commitment to Compliance

Oxzan GxP Solutions is committed to patient safety, product quality, and regulatory excellence. Our regulatory services are designed to meet the evolving expectations of UAE MOHAP, GCC regulators, FDA, EMA, WHO, and ICH, delivering compliant, efficient, and sustainable regulatory outcomes.

Excellence

Patient Safety | Quality | Compliance

OXZAN GXP SOLUTIONS

Comprehensive Regulatory Support

For Pharmaceutical and Non-Pharmaceutical Products across UAE, GCC, FDA, and EU Markets.

Global Regulatory Expertise

From regulatory strategy to post-approval lifecycle management, Oxzan GxP Solutions provides end-to-end compliance support across pharmaceutical and non-pharmaceutical healthcare products, ensuring your products meet regulatory requirements in UAE, GCC, USA, and EU markets.