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PharmaLex Denmark A/S

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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).

Products and solutions

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
Learn more ›

Pharmacovigilance

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 Learn more ›

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 Learn more ›

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 Learn more ›

Case stories

Contact

Torben Thers Nørgaard
info@jacobsenadvice.com

PharmaLex Denmark A/S

Agern Allé 24
2970 Hørsholm
https://www.pharmalex.com/

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