Services
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.
- Get coached on how to pass the authorities' inspection
- Achieve European quality standards for your products
- Avoid losing time and money
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.
- Cut costs and time with an already established testing laboratory
- Out source your testing to our team of experts
Pharmacovigilance
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.
- Benefit of our long standing experience with PV processes
- Ensure patients' safety and satisfaction
- Manage recalls accordingly and avoid legal actions
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.
- Align with ease to the European Unions strict requirements
- Make sure to meet the Regulated Authorities' expectations
- Get your dossier evaluated for submission with the EU authorities
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.
- Support the MAH with the necessary guidance to fulfil the EU requirements
- Keep up to date with yearly reports and other licencing duties
- Make sure that your product stays on the market
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.
What Quintian is
We handle everything for you
Keep your mind on sales and revenue and let us worry about everything else.
Time and budget friendly
We know the industry
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.
Available for consultations
Reach out today and schedule a consultation meeting with our team.