Our Services

Comprehensive Regulatory and Scientific Solutions for the Global Pharmaceutical Industry

Intro Section

Delivering World-Class Regulatory & Scientific Services

At Globaxa Pharma Consultancy, we help pharmaceutical companies navigate complex regulatory frameworks with confidence.
Our services span the entire product lifecycle — from clinical trial support and dossier preparation to regulatory submissions, approvals, and post-marketing surveillance.

With a proven track record across 50+ countries, we combine technical expertise with data-driven precision to accelerate your path to compliance and market success.

Expert Regulatory Team

with 10+ years of experience

Global Coverage

Europe, Asia, Africa, LATAM, and CIS regions

Comprehensive Documentation Support

for all product categories

Our Core Services

Comprehensive Solutions for Regulatory Success

Clinical Trials (Phase I–IV, BA/BE, TV & PMS)

Comprehensive support for clinical trials, BA/BE studies, therapeutic vigilance, and post-marketing surveillance.

Clinical Trials (Phase I–IV, BA/BE, TV & PMS)

Dossier Preparation & Lifecycle Management

End-to-end CTD/ACTD dossier compilation and regulatory lifecycle maintenance.

Dossier Preparation & Lifecycle Management

New Product Registrations & DMF Preparation

Expert assistance in product registrations, DMF preparation, and submissions for global markets.

New Product Registrations & DMF Preparation

Global Regulatory Plant Approvals

Guidance and documentation for manufacturing site approvals and GMP certifications.

Global Regulatory Plant Approvals

Toxicology & Regulatory Services

Specialized toxicology evaluations and compliance documentation for safe product development.

Toxicology & Regulatory Services

Genotoxic Impurity Assessments

In-silico and literature-based impurity risk studies — 1000+ assessments delivered.

Genotoxic Impurity Assessments

Comprehensive Service Portfolio

Beyond core regulatory operations, Globaxa offers advanced scientific and analytical documentation services to support compliance and safety requirements.We help you minimize delays, reduce documentation errors, and achieve faster approvals.

PDE / ADE / OEL Reports

350+ comprehensive assessments completed.

Analytical Support

Extractable & Leachable Impurity Studies (200+).

BA / BE Studies Coordination

with certified CROs and analytical labs.

Why Choose Globaxa

Your Strategic Partner for Global Pharma Growth

Transparency & Integrity

We uphold ethical, transparent, and compliant practices across every engagement.

Scientific Excellence

Backed by a multidisciplinary team of regulatory and analytical experts.

Proven Global Track Record

1000+ successful projects delivered across diverse regulatory territories.