Mapping the requirements
We establish which rules and institutions apply, what each one needs and in what order.
All services
Regulatory & accreditation.
We manage regulatory processes across Romanian and EU frameworks, including medical device compliance, CE conformity, ANMDMR filings, customs and accreditation files.
The challenge
Regulatory work rarely fails on one big obstacle. It slows down through missing documents, unclear requirements and questions nobody has been asked to answer.
What we do
How we approach the work.
Preparing the files
We put together and organize the documentation, including medical device, CE conformity, ANMDMR, customs and accreditation files.
Managing the process
We follow the file through the procedure and keep the work moving until there is a decision.
Framing the open questions
Where the rules leave a question open, we research it and frame it clearly for the right lawyer, tax adviser or institution.
When this helps
- You need a licence, accreditation or approval.
- You are bringing medical devices or equipment into Romania or the EU.
- Nobody can say which procedure applies or who is responsible.
- The rules do not clearly cover your situation.
What you receive
- A step-by-step map of the requirements
- A complete, organized file
- A clear status for every open item
- Clear briefs for your specialist advisers
In practice
A clearly framed question can save months of going back and forth.
International projects often raise questions that local procedures were not written for. On a new hospital, we mapped how internationally trained physicians can practise in Romania.
Read the hospital project