Our project management competencies cover the pharmaceutical industry broadly. From raw material installations and supply systems through API production plants to filling and packaging lines -or complete factories for production of e.g. vaccine.
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.
We offer a wide range of knowledge in strategic and organizational consulting services from risk assessment in industry to administration, GAP analysis, interim management and procurement guidelines - from idea to implementation.
User representatives to prepare requirements related to URS, hardware, software, instruments, calibration, bus systems, data collection, alarm management, validation (FAT, SAT, IQ, OQ, PQ, PPQ/PV, MIT). We perform analyzes and implementations in practice.
We specialize in education and competency development and believe that education and development of people is the way to a better future.
AlfaNordic Academy A/S is a strategic supplier of courses and talents for leading Danish and international companies in the life science industry.
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.
Our QA / QC performs high-end services, compliant with Eudralex Vol. 4 (FDA210 & 211), CFR 820, and ISO 13485, incl. all guidelines. In addition, we provide QC experts, QP delegates and QP assistants.
AlfaNordics Oversættelses- og Korrekturlæsningsteam (OK-team) forstår de regulatoriske forhold i life science-industrien og har mange års erfaring med oversættelser. Vi kan oversætte til og fra alverdens sprog, med få dages varsel, i høj kvalitet, både sprogligt og regulatorisk.