A full support package for your product
The export/import of medicinal products into the European Union is complex and comes with several requirements ranging from licenses and authorizations to the Qualified Person, Batch Certification and Post Marketing Activities.
Manufacturing Site EU GMP Certification
The first step needed to sell pharmaceutical products in the regulated market is to obtain the EU Certification for the manufacturing site. Relying on a qualified partner like Quintian Pharma, you’ll be ready when the inspectors come to your facility.
EU Batch Testing and Release
The last two steps of any drug manufacturing process must be performed inside the European Union in order to get the permission to sell in the regulated market. We at Quintian Pharma have laboratories ready for your company to use.
Once your product is on the shelf, customer care comes in place. What you’ll need is a dedicated team that can answer all your clients questions and doubts about the efficacy of your drug.
EU eCTD Registration
The eCTD is a dossier containing all the information related to a medicinal product that is placed on the EU market. It contains details such as the manufacturing site, ingredients used, pharmacovigilance details and contact information of the Qualified Person releasing the product onto the EU market.
EU Marketing Authorisation Holding
For any dossier that is submitted, a Marketing Authorisation Holder needs to be appointed for taking ownership and responsibility of the product’s marketing licence.
Our work process
Why should I choose Quintian Pharma?
Let us explain why our consulting services are the best on the market.
Keep your mind on sales and revenue and let us worry about everything else.
Before becoming our valuable consultants, our experts have worked extensively in the pharma industry. That’s how we know what you’ll need to pass inspections and achieve compliance.
Reach out today and schedule a consultation meeting with our team.