Copenhagen, Denmark

+45 31 68 88 52

CVR: 38561464

mt@pipadviser.com

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leading
PIP adviser
Europe

Leading PIP adviser in Europe

Succeed with your EMA/FDA Paediatric Development plans (PIP/ PSP)

What We Do

PIP
Strategy

Save resources when aligning paediatric plans with agency expectations.

PIP
Writing

Ensure high quality scientific writing. Manage project teams to succeed in a timely matter.

Health
Agencies

Establish healthy relations with health agencies and sponsors.

Regulatory
Affairs

Defining the right paediatric development strategy,  scope and timelines.

We will create your EU/US/UK
Paediatric Investigation Plan

“Drug developers can no longer ignore paediatric requirements for new medicines, indications, formulations or route of administrations. A paediatric development plan is required both in the EU and US, named respectively Paediatric Investigation plan (PIP), and Pediatric Study Plan (PSP). Furthermore, since Brexit, the United Kingdom now also requires a UK PIP”
"Drug developers can no longer ignore paediatric requirements for new medicines, indications, formulations or route of administrations.. A paediatric development plan is required both in the EU and US, named respectively Paediatric Investigation plan (PIP), and Pediatric Study Plan (PSP)".
Mette Due Theilade Thomsen
PIP expert
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Copyright © www.pipadviser.com

PIP Adviser is a danish based company owned by Mette Due Theilade Thomsen. I use hands-on and in-depth experience to navigate EU, US & UK regulatory requirements and provide high level strategic advice and support to keep you on track.
 
My unique strength as PIP Adviser, is a second-to-none expertise in PIP requirements, supplied by an extensive knowledge and experience.
 
PIP Adviser will cut the time and cost it takes to get your products to patients that need them.

Adress: Stengårds Alle 31A, 2800 Lyngby, Denmark

Phone: +45 31 68 88 52

Email: mt@pipadviser.com

CVR: 38561464