Qualification and validation of plants, equipment, processes (APIs, aseptic processes, packaging processes), cleaning validation and IT / automation. We can manage, review, quality assure or even produce the necessary documentation required to comply with expectations from the authorities.
Experienced resources for preparing batch documentation, deviations, CAPAs, SOPs and related training. AlfaNordic offers chemists and pharmacists who can be part of the production, as well as experienced auditors for internal audits as well as audits of subcontractors and CMOs.
Regulatory advice and strategy as well as practical help for tasks within: Development and approval of new - as well as changes to existing - human and veterinary drugs, medical devices, dietary supplements, cosmetics and medicinal cannabis. We offer help with documentation, compliance, audit, due diligence and medical translations.
AlfaNordic offers customized training that is fully updated with today's standards. We know the challenges the Life Science industry is facing and we offer a wide range of courses on GMP, Good Documentation Practice, Risk Assessment, Validation, GAP analyses, LEAN and Strategy and Organization.
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