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

Dossier Submission

-7 days

Dossier Acceptance

0 day

1st Stop Clock

106 days

Draft Assessment Report

120 days

2nd Stop Clock

160 days

Outstanding issues

180 days

End of procedure

210 days

High Quality PI Translations

+7 days

Granting National MAs

+30 days

Why should I choose Quintian Pharma?

Let us explain why our consulting services are the best on the market.

We are a service provider based in the European Union dedicated to help pharmaceutical companies achieving compliance for the regulated market

Keep your mind on sales and revenue and let us worry about everything else.

We combine an extensive knowledge in the pharma regulatory world with cost-effective solutions tailored for your needs and requirements.

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.