Providing you with Regulatory Affairs Services~
~means your well-educated staff can focus on other important tasks.

Mutual Recognition and Decentralised Procedures
- We can either support you in running MRP and DCP or offer full support covering all steps from compilation of the application forms to obtaining the marketing authorisation.
Readability testing of Patient Information Leaflets
- The test is performed in accordance with:
- EFPIA. General Recommendations for Readability User Testing of Package Leaflets for Medicinal Products for Human Use – Version March 2003.
- MHRA Guidance on the User Testing Patient Information Leaflets- Version June 2005.
- A Guideline on the Readability of the Label and Package leaflet of Medicinal Products for Human Use (European Commission, January 2009).
Abridged applications for generic products
Bibliographic applications
Medicinal Gases
- We also compile applications for medicinal gases in accordance with CPMP/QWP/1719/00 Note for Guidance on Medicinal Gases.
Variations to Marketing Authorisation
- We perform type I and type II variations necessary to update your marketing authorisation.
Renewal of Marketing Authorisations
- In the entire EU.
Compilation of Expert Reports
- We prepare pharmaceutical, clinical and non-clinical Expert Reports.
Compilation of EU format dossiers
- We compile complete registration files and transform registration files from NTA-format into CTD-format.
Preparation of EU Summary of Product Characteristics, Patient Information Leaflets and label texts
Medical Device Support

Preparation of Periodic Safety Update Reports (PSURs)
eCTD
- We can convert your CTD applications to eCTD format.
Drug Master Files
- Review and updates.
Certificate of Suitability (CoS) for active ingredients
- Application including Expert Report.
Professional translations
Review of in-licensing products
- If you plan to acquire a dossier for submission within EU we offer to evaluate the dossier before you decide to purchase it.
Product acquisition and development
- If you are seeking a specific registration dossier or marketing authorisation, we can support you. If you are planning to develop a pharmaceutical product, we can put your company in touch with contract manufacturers specialising in various dosage forms.
Choice of contract manufacturer
- We can help you choose a suitable contract manufacturer for any product.
Logistical support and QP batch release
- Through our network we offer logistical support and QP batch release. We offer specific expertise in regard to importation strategy and repeat EU testing in line with annex 16 of the Guide to Good Manufacturing Practices.
Project management
Product registration strategies
- If you plan a Mutual Recognition Procedure, a certain strategy is required. We can help you plan this strategy and identify any pitfalls from SPC comparison to licensing strategy.
Strategic regulatory consulting
- Issues, obstacles and regulatory requirements are identified for each stage of a product development. Addressing those issues beforehand helps streamline the process, allowing you to stay focused and avoid costly delays.

For other services within the pharmaceutical field which have not been covered here,
please do not hesitate to contact us to find out whether Jacobsen Pharma
can offer a special service for you.

Regulatory affairs consulting

Medical Translations

Pharmacovigilance

PSUR

eCTD consulting

Readability testing and user test

Medical Device

MRP, Mutual Recognition Procedure

DCP, Decentralised Recognition Procedure

PhV

Adverse Event reporting

Pharmacovigilance reporting

E2B

Eudravigilance application

Test and reporting of Medical Device's

Translations, Regulatory affairs consulting in Denmark, Scandinavia, Nordic region and EU
Regulatory affairs, Medical Translations in Denmark, Sweden, Norway and Finland
Pharmacovigilance, Medical, PSUR
PSUR, eCTD consulting
eCTD consulting, readability testing
Readability testing, readability test, user test, user testing
Medical Device
MRP, Mutual Recognition Procedure, Medical Device
DCP, Decentralised Recognition Procedure, PhV
PhV, Pharmacovigilance reporting
Adverse Event reporting, PhV
Pharmacovigilance reporting
E2B, Eudravigilance
Eudravigilance application

Nørre Havnegade 108, DK-6400 Sønderborg - Phone: +4574441936 - Fax: +4574441937 - E-mail: info@jacobsenpharma.dk

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