From single lines to entire factories

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.

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.

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.

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.

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.

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 have since 2005 advised and solved practical tasks, including in the role of PV manager, QPPV, deputy QPPV or local point of contact for Pharmacogivilance. 

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