I mainly focus on a full range of regulatory affairs services within EU and Czech local market following Directive 2001/83/EC.
I guide you from a pre-submission phase with the aim to get regulatory approval, through the phase to assure the dossier´s validity by managing the product´s life-cycle. Providing guidance in regulatory affairs strategy, dossier compliance or communicate your regulatory tasks with the Authority.
I also have a network of flexible regulatory consultants within EU & RoW who covers other specific activities.
Dossier audit or gap analysis
Submission of the suitable dossier can avoid future deficiencies raised by the authorities during the procedure. That is why resolving technical discrepancies prior to the submission save time and cost delays.
I create, discuss or implement your regulatory strategy to ensure a product launch in timely manner, following necessary guidelines and considering relevant costs.
I collaborate with your manufacturing site(s) and other experts to ensure the presented dossier is suitable for the submission containing relevant parts of Module 1-5.
MEDICAL DEVICES & COSMETICS
I help distributors to face the challenges of the New Medical Devices Regulation (EU) 2017/745 by the implementation of new MDR requirements on the local market of the Czech Republic. Or to place cosmetics products on the market in accordance with Regulation (EC) No. 1223/2009 to make them accessible within the EU.
Preparation of instructions for use
Notification with Registry of Medical Devices
I check or prepare instructions for use in the Czech language laying emphasis on its essential contents for the purpose of the product notification.
I support companies who intents or supply medical devices on the market in the Czech Republic to submit an application for notification of their products. And I also communicate with Authority on their behalf with the aim to get an approval letter.
I help distributors to place their products on the local market of the Czech Republic, verify their marketability in terms of chemical composition and assure health claims introduced on the labelling are in accordance with Regulation (EU) No 432/2012 & Regulation (EC) No 1924/2006.
In this case, I provide not just my experience and chemical background but also understand my clients' needs from the position of an occasional nutritionist advisor.
Labelling & health claims
Notification with Authority
I give you my expertise on the acceptable product status in the Czech Republic based on the product composition and intended use. Or I communicate the issue with relevant authorities.
I prepare, assess or correct your labelling in accordance with EU regulation also incorporating additional parts as per Czech requirements.
I ensure the product notification with the relevant authority in order to be marketable in the Czech Republic.