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Larhammar Consulting AB

 Regulatory and pharmaceutical advice for pharmaceutical and biotechnology companies

Examples of services I provide

 Regulatory support and/or management of regulatory work in drug development projects.

 Advice on regulatory strategies.

 Arrange for scientific meetings or regulatory advice with European Regulatory authorities.

 Compilation, submission and follow-up of clinical trial applications, marketing authorisation applications and variations.

 Review of documentation including gap analysis of the quality part of documentation (Module 3) in clinical trial and marketing authorisation applications.

 Follow-up and interpretation of European and national regulations, directives and guidelines.

 On site management of Regulatory Affairs units.

 On site project management in pharmaceutical development of drugs.

 Business development in Regulatory Affairs and pharmaceutical drug development.

 Teaching- and investigational commissions in drug development and closely related business.

 

Upon customer request I also interact with other experts and consultants. If I have no possibility to take on a commission I can propose other consultants.

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Webmaster Martin Larhammar