Copenhagen, Denmark

+45 31 68 88 52

CVR: 38561464

mt@pipadviser.com

OUR SERVICES

leading
PIP adviser
Europe

We know the PIP game

PIP Adviser is the leading PIP development consultancy supporting life science companies all over the world with the single aim to streamline their processes. This is based on a strong and unique foundation from industry and regulatory agencies.

PIP Adviser uses hands-on and in-depth experience to navigate EU regulatory requirements and provide high level strategic advice and support to keep you on track. EU differs from other regions in its regulatory requirement and PIP Adviser knows how to help focusing on the right activities and end-points.

PIP Adviser´s unique strength is Mette Due Theilade Thomsens second-to-none expertise in PIP requirements, supplied by an extensive knowledge on submissions related to paediatric development in other regions, in particular the US and UK.

Examples on support from PIP Adviser includes support on delivering high quality regulatory filings, help to prepare you for Agency meetings and review your submission to give you a clear view on questions that may arise during Agency review.

PIP Adviser will cut the time and cost it takes to get your products to patients that need them.

How may we help you?

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.

PIP Strategy – 360 degrees solutions for succeding with your plan

Extensive experience in providing advice on paediatric strategies for your PIP, PSP and PPSR. This includes strong expert advice on:

How to avoid validation issues and challenging PDCO requests
PIP condition, regulatory precedence, waivers, deferrals
The strategy for paediatric formulations and nonclinical development
The overall paediatric study plan, paediatric study design, modelling and simulation, extrapolation strategies.
PIP modifications and compliance check.
Considerable expertise in advanced therapy/gene therapy PIPs.
Alignment of PIPs, PSPs, and UK PIPs.
Since establishing PIP Adviser, I have been involved in strategy setting for 40+ paediatric plans.

Strong PIP Writing with proven record

High-quality, complete PIP writing service provided by the most experienced expert in the field.
Known for excellent writing skills
Since establishing “PIP Adviser”, I have written more than 10 complete PIPs which have been successfully approved by the PDCO.

Health Agency – Specialist in approach and handling

My detailed experience from many years of employment in the Health Agencies (Danish Medicines Agency and EMA) and later in industry has provided me with a unique understanding of the thinking of the health authorities, of how to approach them and how to handle agency requests in the most fruitful and rewarding way. This expertise has been built up from having seen “both sides of the fence”. This is one of my absolute strengths that makes me stand out from other consultancies.

Regulatory Affairs EU, US, UK

PIP Adviser offers regulatory Science services in EU, US, UK and other markets.

With a strong track record for delivering excellent results in regulatory science to our clients, I focus on completing tasks with high quality in a timely and cost-efficient manner. This includes strong strategic experience with all types of authority submissions including scientific advice.

"The EU paediatric regulation came into force in January 2017. It aims to improve the health of children by facilitating the development and availability of medicines for children from 0 to 17 years, With the regulation came the establishment of the paediatric committee, PDCO, which main role is to determine the studies that companies must carry out in children as part of paediatric investigation plans (PIPs). PIPs are mandatory for all new and marketed patented products. All applications for marketing authorisation for new medicines have to include the results of studies agreed in the PIP".

Mette Due Theilade Thomsen

PIP expert

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