Market access is in our DNA
We can assist you with all type of Regulatory Affairs matters.
We can provide you with all type of service in this field. Being your Person responsible for Regulatory Compliance, PRRC, create submission strategies, planning, external requirement review and many other things. Read more about some of the services we provide below. We cannot mention all of them why just contact us if you have any questions.
WE ARE SERIOUS PEOPLE
WE ARE PASSIONATE
WE ARE DETERMINED
The only contact you need to meet your regulatory needs!
We are a small company but with many contacts around the world. We try to use what fits your needs the best not our needs to invoice. Many things we handle ourself, but sometimes you need local people that speaks the local language to do registrations PMDH registrations in Japan or NMPA in China. For most products and countries we already know the requirements why you shoul not need to you pay for that! In the end we are the experts in Regulatory and Quality!
The first point to ensure predictable market access is to find all external requirements that are applicable in the market(s) you intend to sell your products. In many cases a manufacturer only think about the first market, but thinking ahead of the game and gather the requirements for all foreseeable markets will save money and time later on. It is not only about MDR, IVDR or QSR, there are also other requirements that applies in most markets like in Europe you have Rhos, WEEE and Reach and still many local requirements depending what products you have. Do you have Wifi in the product or Bluetooth using the correct component from the beginning helps.
We help identify all applicable requirements!
Wen you have identified the requirements for your product it is time to start the regulatory planning. This can be in conjunction with a development project but also standalone if done after the project closed. The planning includes what documentation do you need to be able to make submission, what is needed in the countries you target from a regulatory or quality perspective, Do you have distributors, importer, agents locally to make the submissions. Classification of products and conformity route is important.
What is the best route to market access for your product?
What support is needed in a development project from a regulator perspective. We often help companies to be their Regulatory representative in projects, both to support the project but quite often also train the organization on what is required when it comes to regulatory compliance. Some of the bigger companies that are our customers use us as second thought advisers for a proposed regulatory pathway. Typical the project also includes the Regulatory project planning needed to get successful in the role out of the product!
How to ensure your project is teamed up to deliver?
When most people think about Regulatory Affairs they think CE marking, Shonin, 510(k) clearance. And yes, we do all of this! To be very succeful in submissions the prework is important, We typical do a gap analyse to ensure that all documentation exist before making the submission. Getting on hold or RTA letter from FDA will delay the process and you might loose important time in gaining market access!
We do submissions all the time and hence know current best practice!
Main Products we work with
We work with most types of medical devices and in vitro devices, but also research and laboratory equipments!