Hybrid Applications

Overview

Registration of the Marketing Authorization Application (MAA) for a generic product with changes in active substance(s), therapeutic indications, strength, route of administration compared to the reference medicinal product is very complex as the MAA relies on pre-clinical and clinical trials data with respect to the reference product and new data. In such scenario, bridging studies are critical to show the equivalency with the reference medicinal product for on-time registration and receipt of approval for hybrid application through Article 10(3) from EMA/EU Health Authorities.

Freyr, with wide experience in handling MAA submissions for hybrid applications (Article 10(3)), acts as a cost-effective and trust-worthy Regulatory partner to pharmaceutical manufacturers/Marketing Authorization Holders (MAHs) in-order to handle all legal and administrative requirements, along with registration activities, for the medicinal products.

Freyr Expertise

01
Preparation and review of study designs to be performed for bridging studies
02
Pre-submission meetings with the EMA or with other EU Health Authorities
03
Preparation and support of submission packages for scientific meetings with the EMA/EU Health Authorities
04
Regulatory submission road map/way forward for generic and hybrid applications
05
Selection of dissolution parameters/multimedia for performance of dissolution for test product and RMP
06
Support in the preparation of product development report (discriminatory nature of media)
07
Finalizing the specifications for finished products, in-process/intermediates and review of protocols/reports for exhibit batches/stability study
08
Assistance in selection of Regulatory submission procedure i.e. Centralized Procedure (CP), National Procedure (NP), Decentralized Procedure (DCP) or Mutual Recognition Procedure (MRP)
09
Slot booking for MAA submissions
10
Liaise with country HA to act as RMS for MAA filing in DCP
11
Technical gap analysis of source documents/data for adequacy against EU countries specific requirements
12
Compilation, technical review, finalization, publishing and MAA submissions in eCTD format
13
Regular follow-ups with Health Authorities
14
Handling Health Authority (HA) queries with strategies and preparation of response package for submission for marketing authorization approval
15
Translation support during the national phase of the registration in all EU languages

What our Clients Say?

It is good for submission. And I understand today is a holiday, so I have to thank Freyr team for doing this. FDA called us and is trying to close out the CBE-30 filed in March and wanted these documents as soon as possible. So, I truly appreciate your assistance, even on a day off.

President

An Innovative Pharmaceutical Company

This project, eCTD DMF conversion, was against a very tight schedule and required dedicated resources. Freyr provided the dedicated resources needed to meet our immediate Regulatory filing requirements. Freyr was always on schedule/or exceeded the dates outlined in the project plan. All changes were handled within 24 hours and notifications of changes were promptly provided. This project is not yet complete but has been very successful at this point.

Quality Control and Regulatory Manager

USA-based Pharmaceutical company

The ANDA receipt is received! Thank you very much for your hard work, patience and support for our work over the last couple of months. We are delighted that we were able to meet the timeline and hit an important corporate goal of our young company. Thank you again and look forward to working with your team on the next project!

Research and Technology based US pharmaceutical company

Excellent! Congratulations to the team for this accomplishment! Thank you everyone for your hard work on this. In addition, please let us know what is needed for the submission of the Type III DMF to Health Canada. I assume we will need to update some of the initial administrative documents, but most of the content is identical to the Type IV DMF.

Senior Research Assistant,

US based leading biopharmaceutical company

We have crossed two important milestones in two days, thanks in a large measure to all of you. We are a small company, a small set of people with big dreams. And given the industry we are in and how we operate, it is possible to realize our dreams only with the help of partners like you - who share our beliefs and push hard with their own collective might. On behalf of our organization, I would like to thank you for your competence and commitment in delivering ANDA files. Kudos to the whole team.

Operations Head,

A Privately Held Pharmaceutical Research and Development Company

Thank You Freyr team for a Fantastic 2019! The OTCDOCS TD user community feels better supported despite the technical challenges and system constraints. Thank You for being the voice to represent their ways of working and helping us design a more user friendly, effective system going forward.

System Owner,

UK multinational pharmaceutical company

Great job with your impact and for noticing that there was an error on the insert SAP code. This shows great attention to detail as well as expertise in all the other point areas that you are thoroughly investigating, regarding the QA database etc.

Graphics Manager | Global Regulatory Affairs,

Canada based, global pharmaceutical company

Hybrid Applications

Overview

Freyr Expertise

Regionwide Expertise

What our Clients Say?

President

Quality Control and Regulatory Manager

Senior Research Assistant,

Operations Head,

System Owner,

Graphics Manager | Global Regulatory Affairs,

Get in Touch

USA

UK

GERMANY

INDIA

More Locations

Quick Inquiry

Hybrid Applications

Overview

Freyr Expertise

Related Services

Regionwide Expertise

What our Clients Say?

President

Quality Control and Regulatory Manager

Senior Research Assistant,

Operations Head,

System Owner,

Graphics Manager | Global Regulatory Affairs,

Subscribe to Our Newsletter

Get in Touch

USA

UK

GERMANY

INDIA

More Locations

Quick Inquiry