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 regulatory compliance pathways, enabling life sciences companies to enter global markets efficiently while adhering strictly to regional health authority guidelines. Comprehensive Registration Capabil...

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 lucrative opportunities, expand product portfolios, and forge long-term international partnerships. Key Business Development Services: Market Intelligence & Analysis: Feasibility studies, competitive eva...

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 coordination aligned with the requirements of each country. The service scope may include pharmacovigilance system setup, coordination of a local responsible person, individual case safety report managem...

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 manufacturing plants, GDP warehouses, and specialized medical facilities. Facility Engineering Scope: Pharmaceutical Plants (GMP): Conceptual design, cleanroom classification, HVAC architectural ...

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 complex approval ecosystems seamlessly. Regulatory Advisory Services: CTD & ACTD Dossier Preparation: Compilation and technical writing of Modules 1 through 5 in full alignment with ICH guidelines. ...

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 official health authority inspections. Quality & Audit Services: GMP Inspection Readiness: On-site and remote pre-audit assessments for pharmaceutical manufacturing facilities. GDP Supply Chain Audit...