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In sgm consulting we have more than 50 years of experience from the pharmaceutical industry (Novo Nordisk, ALK-Abelló, Orion Pharma and other head quarters and affiliates). Our competencies are mainly within Quality Assurance, Regulatory Affairs, Production and Project Management.

Our services are:

Quality Assurance (according to GMP, GDP, ISO 9001, ICH Q10, ISO 14001, OHSAS 18001, Lean)

Quality Management Systems (development/improvement, implementation, SOP, Quality Manual)

Regulatory Affairs (New applications, Variations, SmPC/PL/Labelling, eCTD, XEVMPD, Registration Status Systems, Document Handling Systems)

Training and Audit (internal/external, GMP, GDP, Environment, Occupational Health and Safety, Mock-audit)

Project Management (e.g. submission of new application, preparation for audit/inspections – cross countries, cross companies)