Home » Danish Solutions » PharmaLex Denmark A/S

PharmaLex Denmark A/S

What we offer

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).

Regulatory Affairs
Compliance expertise is guaranteed with our RA experts located around the world. PharmaLex is uniquely positioned to ensure that your products meet all regulations and laws no matter where you are. Our teams have successfully managed multiple large-scale projects through to the post-market phase. We can position you for success from the initial development of new medicines all the way through to market readiness. We are your strategic partner, playing a key role in your success by outlining a tactical, target-oriented plan, flexible based on the ever-changing regulatory field. Authority Communication Classification of Changes CMC and Medical Writing for Development CMC and Medical Writing for Submission Customer On-Site Support Dossier Preparation, Submissions & Approvals Drug Product (production, formulation, and scale up) eCTD Consultancy eCTD Publishing all formats Global Regulatory Strategy IND/ IMPD Compliation and Submission Labeling/PI/CCDs Management Globally Marketing / Labeling Activities Processing & Submission of Marketing Authorization Application Processing of Clinical Trial Application (CTA) Regulatory Intelligence Rx to OTC Switch Scientific Advice / Pre-Submission Meetings Second Wave Submissions/ Global Roll Outs Technical CMC / Medical Writing & Dossier Updates Technical Support for CMC / Quality

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

Development Consulting
Let our experts design a strategic solution that is tailored to your needs. Having led many successful efforts with multiple regulatory agencies around the world, PharmaLex can leverage years of professional experience to help move theory into action. We have managed successful development efforts from the initial idea and incubation stage through new product approval (or market authorization) and have provided post-market analysis. Authority Communication Branding Clinical Trial designs & study set-up Clinical Trial Monitoring CMC and Medical Writing for Development and for Submissions CRO Assessment & Selection Development CMC / QBD Development Strategy & Gap Analysis Discovery Chemistry / Biology Global Regulatory Strategy Health Economics & Outcomes Research (HEOR) IND/ IMPD Compliation and Submission Labeling/PI/CCDs Management Globally Market Research / Assessment / Value Inflection Points Marketing / Labeling Activities Medical Affairs (incl. information services) Non-clinical studies Preparation for Regulatory Bodies Pricing & Reimbursement Protocol Development & Review (Phases I – IV) Regulatory Authoring (including QA & Review) Rx to OTC Switch Scientific Advice / Pre-Submission Meetings Scientific and Medical Writing Scientific Due Diligence Statistical Services / Clinical & non-clinical Study Management & Selection Technical CMC / Medical Writing & Dossier Updates Technical Support for CMC / Quality

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
Agern Allé 24
2970 Hørsholm

Read more
Sign up for our newsletter
Interested in experiencing Danish healthcare solutions?