PharmaLex Denmark A/S is a part of PharmaLex Group. PharmaLex is one of the largest providers for Development Consulting, Regulatory Affairs, Quality Management & Compliance and Pharmacovigilance worldwide. In the Nordics, we have offices in Hørsholm (Copenhagen DK), Oslo (No) and Gothenburg (SE).
What we offer
Put your pharmacovigilance concerns in experienced hands. Whether you need an urgent solution for an unexpected problem or are seeking to outsource your entire pharmacovigilance processes – our experienced experts will be there for you. Aggregate Report Writing EU-QPPV / Local-QPPV ICSR, Signalling and Risk Management Pharmacoepidemiology Pharmacovigilance & Clinical Safety Risk Management Plan VigiLit: Literature Surveillance
Quality Management & Compliance
We provide services across a company’s life cycle from helping emerging companies set-up quality systems and generate SOPs to assisting mature companies review batch records, audit suppliers and manage consent decrees. When a biopharmaceutical, medical device or diagnostics company needs a QA consultant, it’s usually for one of two reasons. Either they need someone who can provide high-level leadership and guidance in establishing the company’s QA practices from the ground up or they need someone who can step in to supplement existing staff during busy times. We address both types of needs. Our roster of consultants ranges from strong mid-level talent, to some of the highest skilled, senior-level talent in the industry. Our goal: match your needs with the right person for the job. Auditing Batch Disposition & Deviation Resolution GMP/GCP Supplier Management GxP Services Inspection Support & Remediation Product Complaint Management QMS Development Supply Chain Management