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)