FDA - U.S. Food & Drug Administration (USA)

EMA - European Medicines Agency (Europe)

MHRA (UK)

Health Canada (Canada)

PMDA (Japan)

TGA - Department of Health (Australia)

Swissmedic (Switzerland)

CDSCO (India)

HSA - Health Sciences Authority (Singapore)

SFDA - Saudi Food & Drug Authority (Saudi Arabia)

ANVISA (Brazil)

Medsafe (New Zealand)

SAHPRA (South Africa)

EDA - Egyptian Drug Authority (Egypt)

Roszdravnadzor (Russia)

Ministry of Healthcare (Kazakhstan)

Center for Pharmaceutical Products Safety (Uzbekistan)

AEM - Analitik Ekspertiza Mərkəzi (Azerbaijan)

Ministry of Health (Iraq)

TMDA - Tanzania Medicines and Medical Devices Authority (Tanzania)

About Us

Your Global Partner in Product Registration, Market Expansion & Drug Safety

Established in 2013 in Baku, Azerbaijan, Makromed is a pioneer consulting and service provider in pharmaceuticals and regulatory processes across the globe. With a strong international presence and local offices in Azerbaijan, Uzbekistan, India, Russia, and Georgia, we connect businesses with opportunities worldwide. Makromed brings together deep regulato ...

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550+

Global Pharma trusted by pharmaceutical companies worldwide

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250+

Global Trusted Pharmacovigilance Clients

1
1000+

Registered Drugs across multiple therapeutic categories

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1500+

Approved Food Supplements from herbal to nutraceutical brands

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2000+

Registered Medical Device Across Diverse Device Categorie

1
90+

Global Countries Covered Presence Across Global Markets

1

Services

Global Pharmaceutical & Regulatory Solutions

Product Registration: Medicines, Devices & Nutraceuticals

Global Product Registration for Pharmaceuticals, Medical Devices & Nutraceuticals Makromed is a premier regulatory consulting organization offering end-to-end market authorization solutions for pharmaceutical products, medical devices, and nutraceuticals (dietary supplements). We simplify complex r...

Business Development & Partnering

Strategic Business Development and Global Healthcare Alliances Sustainable growth in the pharmaceutical and healthcare sectors requires strategic foresight, robust commercial networking, and market alignment. Makromed acts as a strategic growth partner, helping healthcare companies identify lucrati...

Pharmacovigilance (Local, Regional & Global PV Systems)

Pharmacovigilance services across international markets Makromed provides pharmacovigilance services to pharmaceutical manufacturers, marketing authorisation holders, distributors and local affiliates. We support projects in Azerbaijan, Uzbekistan, Georgia, India and Russia through central coordi...

Medical Design & Facility Planning

Specialized Medical Design & Facility Engineering for Healthcare & Pharma Designing healthcare facilities and pharmaceutical infrastructure requires a precise blend of engineering expertise and stringent regulatory compliance. Makromed provides master planning and design services for hospitals, GMP...

Regulatory Affairs, Dossier Management & Market Entry Support

CTD/ACTD Dossier Management, Gap Analysis, and Market Access A well-structured regulatory dossier is vital for swift market clearance. Makromed offers complete lifecycle management for regulatory dossiers, performing rigorous gap analyses and providing strategic market entry support to navigate com...

GxP Audit & Compliance (GMP Audit and Inspection Support)

GxP Quality Assurance, GMP Inspections, and Compliance Consulting Maintaining uncompromised quality standards across manufacturing and distribution is mandatory for pharmaceutical compliance. Makromed offers specialized GxP (GMP, GDP, GCP) audit services to prepare your facilities for rigorous offi...

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