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Regulatory Affairs

Regulatory Affairs – EU, MENA & LATAM.

 

Since initial quality of your dossier is only one of the variants for a successful registration and life cycle of your product. In consequence, at Baupharma, we pay special attention to get the best result out of your files. Hence, we can work from gap analysis to registration, renewals and variations, or every single document you may need during the process. In Baupharma we have an experienced and flexible team specialized in EU, MENA & LATAM regions. As a result. Baupharma is ready to work with you on full basis or focus on the documents, questions or services you require.

Regulatory Affairs – EU, CIS, MENA. Registration Medicinal products.

 

In order to give you an overview, below you can see the list of the services:

  • CP (EU), DCP (EU, MENA), NP (EU, MENA, LATAM), Variations and Renewals
  • Gap Analysis
  • Full Submission and Regulatory Support
  • Module 1 preparation including:
    • Cover letter
    • Application form (eAF)
    • Artwork and Braille
    • Consultation with Target Patient Groups (Readability Testing in all EU languages)
    • Environmental Risk Assessment
    • PSMF
    • RMP
    • CPP
  • Module 2 preparation:
    • 2.4 Nonclinical Overview
    • 2.5 Clinical Overview
    • 2.6 Nonclinical Summary
    • 2.7 Clinical Summary
  • Publishing
    • eCTD Publishing
    • Nees/CTD to eCTD
  • Submission to Agency
  • Regulatory Intelligence

If you are interested in further information, get in contact with us at regulatory@baupharma.com

Regulatory Affairs – EU, CIS, MENA. Registration Medicinal products.

 

Translations

Also, as you know, a proper translation is key in our sector: from a successful registration or renewal, the right use of literature, the correct processing of adverse reactions and events or a consistent use of your pharmaceutical marketing material on a global level.

Our team of experienced translators  and project managers are here to assist you through the whole process. These are some of our characteristics:

  • Medical translators
  • Emphasis on local legislations and requirements
  • Tight deadlines
  • Legalized translations
  • Specialized in:
    • PL, SmPC and labelling
    • Literature articles
    • PHV: adverse reactions and events
    • Pharmaceutical marketing
    • Full dossiers

In regards translations, our in-house team will evaluate with you the best approach for the work.

Also, if you are interested, you can send your questions or requests to regulatory@baupharma.com

Regulatory Affairs – EU, MENA. Registration Medicinal products.

 

Consultation with target patient groups

Due to the legislations in EU, if you have a new product and you want to register it you should present a report or statement in this subsection of your eCTD submission.  While this subsection is mandatory, we have different solutions and approaches depending on your product.

Nowadays, you have several ways to meet the requirements of  this section. Seeing that many products have been registered already, the agencies accept different types of reports depending on your product. What do we mean and how we do it? See below and you will find your answer. For the purpose of information, the selection of the strategy is key for a secure, fast and also economic approval from the Agency.

Readability Testing:

This report proves the legibility of Product Information Leaflet (PL) of the product to be marketed. In consequence, this report should cover the legibility of content as well as design. Both should follow EU and local guidelines but, specially, the results of the report have to be acceptable after the interviews with the participants that will read the PL.

To begin with, our first step will be the mockup. Baupharma can design mockups according to your indications and following local and EMA requirements. Secondly, we will prepare a questionnaire following the guidelines of EMA. In order to probe the legibility of the PL, we will perform 3 rounds of interviews with 22-24 participants. Likewise, the population will be assigned according to the language of your leaflet. In the event of an English leaflet,  interviews will be in UK and on English speaking interviewed. If is in Italian, in Italy and so on according to the different languages in the EU (Note: some countries accept readability tests in English even if the official language is different). Once we have the results, a report will be prepared with the final analysis. Since deadlines are time sensitive, we can perform the full process in 10 natural days.

Bridging report and double bridging report:

In the scenario of a similar product already registered or if an Agency has published the PL of a similar product, we can use the information on your report. In the same way, bridging and double bridging cover 2 main sections of analysis: content and design. Firstly, we will perform an analysis agains an already approved product. On the later, we will analyze the similarities and differences between the mockups of the new and already registered product. Since interviews are not required, final report can be ready in 2-3 natural days.

Bridging statement:

Such as  products already tested that are exactly as the new product, a bridging statement is the strategy that we recommend. For example,  this is commonly seen in products with different strengths that keep the same text. Likewise, in the case of different dosage form that has a minor impact on the text. This statement is ready in 1 day.

Focus Test:

If a product with no more than 5 important differences was registered or published by an Agency, we can use the information on your report. In this case, we would performa a readability testing of only 5 questions about the differences. In order to justify them, we will use the results of the questions and perform an analysis on the rest of the PIL. This report is ready in 7 to 10 days.

Similarly, if you are interested in further information, get in contact with us at regulatory@baupharma.com

Regulatory Affairs – EU, MENA. Registration Medicinal products.