Centre of Excellence
End-To-End Regulatory Labeling

Two Players one Team

mpü Labeling Translation + orangeglobal Regulatory Labeling 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 + og offer a broad spectrum of regulatory end-to-end services ranging from the creation to marketing authorisation, including lifecycle management, of your product information.

As a result of the many years of comprehensive practical expertise acquired by the partners, mpü + og, 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.

End-To-End Advantages with mpü

Our regulatory labeling includes

Creation of English labeling documents

forming part of the dossier (Module 1.3.1)

Advising on and implementing RUT readability testing of the package leaflets

(Readability User Test, Focus Test, Bridging Report) in compliance with official requirements (Module 1.3.4)

Translation into 24 EU/EEC languages

and delivery of the final labelings

Marketing Authorisation + Linguistic Review

without delay, despite time-critical authority requirements

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

Tell us about your project – our labeling project management will be happy to give you comprehensive advice:

Lifecycle management of your product information in 24 languages

Management and coordination of the entire regulatory labeling process for all EU/EEC registration and approval procedures pursuant to national and European law.

CP – DCP – MRP – NP – Variations – National Notifications of Change (PRAC) – Line Extensions – Renewals – PSURs

mpü Labeling Expertise

An established and proven end-to-end labeling 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 prescribing information

Translation - 24 QC-tested language versions

mpü Expertise

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

– Quality checking of the labeling on all standard requirements such as EMA QRD, EDQM, excipient guidelines, 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

-Customer corrections: Management of review by the customers’ country subsidiaries

Quality assurance
 

mpü Expertise

Internal quality checks with specific process stages 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 EN DIN 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 package leaflet (PL) -> complete readability test or focus test or bridging report by volunteers

PL preparation

– Adaptation to the SmPC and/or official requirements
-Checking for patient-friendly formulation and layout

RUT

-Creation and printing of the package insert to be tested (PL)
– Pilot test: 3 volunteers
– Main test: 2 x 10 volunteers
– Tests in all 24 EU languages, predominantly in EN and DE
– Final report in English for submission in the dossier, Module 1.3.4,
PL in language tested in Module 1.3.1.

Focus tests

– Creation and printing of the daughter PL to be tested
– 1 x 10 volunteers
– Tests in all 24 EU languages, predominantly in EN and DE
– Final report in English for submission in the dossier, Module 1.3.4, PL in English in Module 1.3.1.

Bridging reports

– Advice on whether bridging is possible for your package leaflet
– Creation of the daughter PL
– Creation of the bridging report according to the requirements of the official CMDh or EMA templates
– Depending on the customer’s wishes, content and layout bridging or pure content with or without layout bridging

Regulatory artwork

– Draft of the package leaflet (PL) according to customer requirement and based on og experience taking legal requirements into account
-Printing the PL (mock-up) on paper of the desired paper weight

Linguistic Review

orangeglobal Expertise

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

-Handling all communications…

…between authority and translator

-Content and linguistic processing of feedback from the authority

-Rapid problem solving based on medical and regulatory know-how in all queries and finalisation of the labeling (QRD Form 2)

orangeglobal Labeling Expertise

Regulatory expert knowledge 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 labeling 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 + Labeling translation team

Our experienced project management and regulatory team as well as our experienced team of labeling 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 3000 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

Have we persuaded you that the end-to-end labeling solution offered by mpü and og is right for your project?

Our labeling project management is looking forward to receiving your enquiry:

Talk to us.