Regulatory labelling

Two players – one team

mpü labelling translations and orangeglobal regulatory labelling expertise

Our partnership and associated strategic positioning is a clear response to the needs of pharma and biotech companies dealing with marketing authorisation projects. Through our partnership, we can now provide our customers with an exceptional and holistic approach in the EU.

mpü and orangeglobal offer a broad spectrum of regulatory services ranging from the creation to marketing authorisation, including life cycle management of your product information.

As a result of the many years of comprehensive practical expertise acquired by the partners at mpü and orangeglobal, we enable our pharma and biotech customers to achieve their regulatory objectives without compromise or delay.

The highest reliability and quality, “tailor-made” solutions and professional management ensure acceptance by the regulatory authorities and compliance with tight timelines.

In centralised procedures (CP) for example, after a positive opinion all language versions must be finalised in only 5 working days over the weekend.

mpü + orangeglobal (og) bieten ein breites Spektrum an re­gu­la­to­ri­schen Services, die von der Erstellung bis zur Zulassung sowie dem Life Cycle Management Ihrer Produktinformationen reichen.

Durch die langjährige und umfassende praktische Expertise der Partner mpü + orangeglobal (og) ermöglichen wir unseren Pharma- und Biotech-Kunden, dass sie ihre regulatorischen Ziele uneingeschränkt und verzögerungsfrei erreichen.

Höchste Zuverlässigkeit und Qualität, „Tailor-made“ Lösungen und professionelles Management gewährleisten Behördenakzeptanz und die Einhaltung von engen Zeitschienen.

Zum Beispiel bei zentralen Verfahren (CP) nach der Positive Opinion nur 5 Arbeitstage über das Wochenende, um alle Sprachversionen zu finalisieren.

Advantages with mpü

Our regulatory labelling services include

Creation of the English labelling documents

forming part of the dossier (module 1.3.1)

1

Advising on and implementing RUT readability testing of the patient information leaflets

(readability user test, focus test, bridging report) in compliance with official requirements (Module 1.3.4)

2

Translation into 24 EU / 26 EEA languages

and delivery of the final labels

3

Marketing authorisation and linguistic review

without delay, despite time-critical regulatory requirements

4

The solutions provided by the mpü and orangeglobal partnership offer strategic and regulatory options to facilitate the marketing authorisation process for you.

Talk to us about your project – our labelling project management team will be happy to give you comprehensive advice

Life cycle management of your product information in 24/26 languages

Management and coordination of the entire regulatory process for your labelling in all EU/EEA registration procedures according to national and European law.

CP – DCP – MRP – NP – variations – national notifications of amendments (PRAC) – line extensions – renewals – PSURs–PBRERs

mpü labelling expertise

An established and proven labelling process:

Creation of the English product information

orangeglobal expertise

Review/assessment and updating/structuring or creating the English product information

  • Review/assessment and updating/structuring of the existing English product information texts to ensure they can be registered in accordance with European directives
  • Regulatory medical writing – creation of the English product information (based on the CCDS – Company Core Data Sheet/CCSI – Company Core Data Information)
  • Creation of mandatory texts

Translation – 24 or 26 QC-tested language versions

mpü expertise

Professional and high-quality translation, revision and quality checking of the labelling in accordance with DIN EN ISO 17100 in all 24 EU/26 EEA languages

  • Quality checking of the labelling on all standard requirements such as EMA QRD, EDQM, guidelines on excipients, MedDRA, lay terms, etc.
  • Country-specific adjustments such as blue box requirements
  • Synchronisation/creation of documents for different product strengths and routes of administration
  • Formatting based on EMA QRD conventions, national requirements or customer specifications
  • Creation of Member State versions
  • Review by the customer’s country subsidiaries:
    management of the review and implementation of corrections.

Quality assurance

mpü expertise

Internal quality checks with specific process steps and special QC tools

  • Quality assurance by internally established quality control processes and trained and experienced project management. We have set up quality assurance in accordance with our DIN EN ISO 17100 and 9001 certification.
  • Only native-speaker, certified and professionally trained translators or experts are used for translation and revision.
  • Confidentiality agreements with customers and suppliers ensure confidential processing of the documents.

Readability user test

orangeglobal expertise

RUT – readability compliance

RUT – the readability user test demonstrates the readability and intelligibility of the patient information leaflet (PL).

RUT – the readability user test demonstrates the readability and intelligibility of the patient information leaflet (PL) using test subjects → full readability user test, focus test or bridging report

  • PL preparation
    • Adaptation to the SmPC and/or official requirements
    • Checking for patient-friendly formulation and layout
  • RUT
    • Creation and printing of the patient information leaflet (PL) to be tested
    • Pilot test: 3 test subjects
    • Main test: 2 × 10 test subjects
    • Tests in all 24 EU languages, mainly in English and German
    • Final report in English fully formatted for insertion into the eCTD – dossier module 1.3.4, PL in the tested language in module 1.3.1., PL mock-up in module 1.3.2.
  • Focus tests
    • Creation and printing of the patient information leaflet (PL) to be tested
    • 1 × 10 test subjects
    • Tests in all 24 EU languages, mainly in English and German
    • Final report in English fully formatted for insertion into the eCTD – dossier module 1.3.4, PL in English in module 1.3.1., PL mock-up in module 1.3.2.
  • Bridging reports
    • Consultation on the options for bridging for your patient information leaflet
    • Design of the daughter PL mock-up (on request)
    • Creation of the bridging report according to the specifications of the official CMDh or EMA template
    • Depending on the customer’s wishes, content and layout bridging or pure content with or without layout bridging
  • Regulatory artwork
    • Draft of the patient information leaflet (PL) layout according to customer requirements and based on orangeglobal experience taking into account legal requirements
    • Printing of the PL mock-up on paper of the desired paper weight up to a size of DIN A0, including as colour printing

Linguistic review

orangeglobal Expertise

Established contacts with partners in the Member State authorities in all EU countries

Handling of all communication

  • Handling of all of the communication between authorities and translators
  • Content and linguistic processing of feedback from the authority
  • Rapid problem solving based on medical and regulatory expertise in all queries and finalisation of the labelling (QRD Form 2)

orangeglobal labelling expertise

Regulatory risk management completes the translation process

Our contacts with experts on marketing authorisation in all EU countries ensure the rapid provision of information.

Acceptance by the authorities based on our specialist knowledge, strategic approach and operative experience in all EU procedures.

Project training and briefing for all those involved with the project are undertaken by regulatory specialists.

Regulatory expertise is involved at all stages of translation and clarifies any problems with translators and revisors.

Regulatory specialists assist with the process and solve all specialised issues arising in qualified exchange between customer and expert. This reduces reworking by the customer or further enquiries by the authority.

mpüPLUS

ExpertisePLUS

Confidence in acceptance by the relevant authority

Through long collaboration in the creation and translation of all labelling texts, regulatory affairs specialists from orangeglobal and translation specialists from mpü ensure high-quality and specialist results in all EU languages required and in all timelines specified.

ExpertisePLUS

Cooperation between linguistic and specialist knowledge

Language processes – trained project management – regulatory specialists cooperate promptly on a daily basis and are able to cope with all problems.

ExpertisePLUS

Project management + labelling translation team

Our experienced project management and regulatory team as well as our experienced team of labelling translators have mastered the strict time management of the critical deadlines, so you are equipped to deal with all the requirements associated with these time constraints.

orangeglobalPLUS

ExpertisePLUS

RUT – focus test – bridging

With our experience from more than 3,000 readability tests we are well prepared to handle your projects.

ExpertisePLUS

Creation of the medicinal product dossier for electronic submission in eCTD format

eCTD service

eCTD service including creating baseline eCTD sequences

Reformatting of authorisation dossiers from the NtA into the CTD format or into NeeS structures

ExpertisePLUS

Scientific advice.

We assess existing documents/dossiers, indicate useful strategic and regulatory options and assist you with scientific advice in relation to the competent authority.

Regulatory compliance

GAP – analysis of marketing authorisation and manufacturing documentation and revision of the related regulatory documentation

Due diligence

Assessment of the application documents for conformity with regulatory requirements before submission to the competent authority

FAQs

In pharmaceutical and biotech companies, Regulatory Affairs is the division that is responsible for the regulation of medicinal products and other health-related products. This comprises complying with legal requirements, applying for and maintaining registrations and communicating with supervisory authorities. The goal is to ensure the safety, efficacy, and quality of products so they can be brought to market without any delays and in line with the regulatory requirements.

mpü would be happy to support you with consultations with experts and the creation of registration documents through to the life cycle management of product information including translations and language services. Our services also include performing readability user tests for patient information leaflets and adapting texts to improve the intelligibility of the contents for patients (lay translations).

The existence of Regulatory Affairs is essential to ensure patient safety and protect public health. Since medical devices and medicinal products directly impacts the health, they need to comply with strict regulatory standards. Regulatory Affairs ensures that these products are effective and safe and undergo all necessary registration processes.

New scientific findings, technological advancements and changing social requirements mean that laws and regulations must constantly be adapted. Therefore, Regulatory Affairs experts are essential to help companies keep up with these changes.

Regulatory labelling relates to the process of creating, reviewing, and updating labels and patient information leaflets for medical devices and medicinal products. These labels contain important information such as dosage instructions, ingredients, adverse reactions and warnings.

Here at mpü, we offer specialised services in the field of regulatory labelling, including translations into various languages to ensure that this important information is accessible to a wide audience. Our services also ensure that the labels comply with the official requirements, which is essential for international marketing and patient safety.

Have we persuaded you that the labelling solution offered by mpü and orangeglobal is right for your project?

Our labelling project management is looking forward to receiving your enquiry.