Your One Source
Welcome to Ashab Group - Your trusted Pharmaceutical Consultancy Partner
At Ashab Group, our expertise offers strategic guidance to help you navigate the complexities of
global regulations, ensuring your pharmaceutical products are compliant and ready for market
success.
Quality Products
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Regulatory Approvals
We provide end-to-end support for obtaining approvals from global regulatory authorities. Our team specializes in pre-inspection audits, gap analysis, and quality management system implementation to help pharmaceutical, medical device, and healthcare companies meet international compliance standards seamlessly.
Why choose us
Years of Expertise
With a team of seasoned professionals boasting years of experience in pharmaceuticals, medical devices, and dietary supplements, we bring unparalleled knowledge to every project. Our consultants combine deep industry insights with technical expertise to deliver results that align with your business goals.
Global Reach
Our extensive global network enables us to provide regulatory and clinical services across multiple continents. Whether your focus is the US, Europe, Asia, or emerging markets, we leverage our international expertise to guide you through region-specific requirements, ensuring seamless product registrations and approvals.
No-Error Dossiers
Our meticulous attention to detail ensures that all dossiers are error-free, saving time and preventing delays.
Compliance with International
Standards
We work with EU-GMP, ANVISA, WHO- GMP, and more to ensure global regulatory compliance.
Customizable Services
We adapt our services to meet your specific requirements, providing flexibility and precision.
Skilled Team
Our team is equipped with the knowledge and tools needed to navigate complex regulatory landscapes.
Systematic Methodology
We follow a proven, structured approach to achieve the best outcomes for our clients.
Commitment to Quality
Quality is our top priority, ensuring every deliverable exceeds client expectations.
Our Services
REGULATORY APPROVALS
Secure global market approvals and ensure continuous compliance through inspections,
audits,
and gap analyses for pharmaceutical facilities and quality systems.
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REGULATORY APPROVALS
REGULATORY AFFAIRS
Expertly prepare, review, and submit complex regulatory dossiers, reports, and documents
to
navigate the approval processes in key international markets.
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REGULATORY AFFAIRS
SERVICES FOR EUROPE SUBMISSION
Provide full-service support for European marketing authorization, qualified person
responsibilities, pharmacovigilance, and product batch release/testing to enable
successful
EU launches.
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SERVICES FOR EUROPE SUBMISSION
TECHNOLOGY TRANSFER
Leverage our R&D expertise and EU-approved dossier knowledge to seamlessly transfer
products
and processes, accelerating your time to market.
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TECHNOLOGY TRANSFER
Medical Devices
We provide expert regulatory, clinical and compliance services to Pharmaceutical medical device manufacturers.
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MEDICAL DEVICE
TOXICOLOGY SERVICES
Comprehensive risk assessments, safety evaluations, and biocompatibility studies for
pharmaceuticals, medical devices, and cosmetics to ensure product safety and regulatory
compliance.
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TOXICOLOGY SERVICES
Global Experience and Expertise
We have submitted dossiers to various countries across regions like SEA, LATAM, Middle East, CIS, Africa, and Europe.