Regulatory Affairs

What is Regulatory Affairs?

Through the preparation, submission, and management of regulatory documents and interactions with regulatory agencies, we ensure the best procedure for your product for smooth marketing authorization. We help you with product information in local languages in Finland, Sweden, Norway, Denmark, Estonia, Latvia and Lithuania for Human Medicinal products; both pre-submission services and marketing authorization maintenance services.

Our services

Full eCTD services  
Common Nordic and Baltic Packages 
Pre-submission services  
Marketing Authorization Maintenance services 
Launch support and life cycle services -Databases
Blue box requirements 
Abbreviated SmPC’s
Price notifications 
Translations management and coordination  
RA Intelligence
Training 

Presubmission services 

Before your product marketing authorization application is ready for submission, there are lots of activities to be performed. We help you with all of them, for example

  • Services
    • Technical Review of Marketing authorization application dossiers  
    • Preparation and Compilation of eCTD sequences  
    • Preparing of local documents such as Cover letter, eAF, eAF annexes, Product information 
    • National Phase activities for Marketing authorization applications (preparing and submitting national Product Information and mockups of labelling) 
    • Submission of Marketing authorization applications dossiers via Common European Submission Portal (CESP)  
    • Common Nordic Packages; Strategy planning, preparing national Product Information texts, correspondence with Nordic authorities 
    • Review and translation of product information from English to Finnish, Swedish, Norwegian or Danish, inclusion of local requirements  
    • Mockup / Artworks management, also in client system if needed. 
    • Support to Risk Minimization processes, local activities 
    • Preparing and compiling response

Marketing authorization maintenance 

You can leave your marketing authorization in good hands; we will do all necessary activities to keep your marketing authorization valid. You just inform us about need of changing something, and we help you with 

  • Services
    • Compilation of variation application dossiers / notifications  
    • Submission of dossiers via common European submission portal (CESP)  
    • Preparing and compiling responses 
    • Updating of product information / printed packaging materials 
    • National Phase activities for Marketing Authorizations (updating local data bases, notifications of new products to the market) 
    • Product information management in local databases
    • Activities in Vnr database 
    • Pharmaca Fennica and Pegasos in Finland 
    • FASS in Sweden o Felleskatalogen in Norway 
    • DKMAnet in Denmark 

Launch support and life cycle services – Databases  

Our experienced staff knows the databases your product should be to ensure it is visible and available. We help you if you struggle with supply disruptions. 

  • Services
    • Vnr database in Nordic countries; application and management of your Vnr numbers
    • Placing product on market (Vnr database in Finland, LiiV in Sweden and more) 
    • Ensuring your Product information is visible for HCP’s and consumers –local databases (Pharmaca, Pegasos, Fass, Felleskatalogen, DKMAnet) 
    • Notifications to local authorities 
    • Price notifications
    • Reimbursement notifications 
    • Communication with wholesalers, complaints and other feedback 

Blue box requirements  

We know how to implement all blue box requirements in Nordic and Baltic countries –also in cases where there are conflicting requirements –Red Warning Triangle, Vnr number, and more.

Abbreviated-SmPC’s  

We create SmPC abbreviations to be included to your marketing materials. Whether you have your own guidelines, or you wish us to follow local ethical and compliance rules, we will provide with you high quality abbreviations of your SmPC’s.

Price notifications  

We create your first price and reimbursement application, and keep it up to date during product’s life cycle. We can follow up your product prices validity periods and suggest to you when it is time to renew your products price, or we can act according to your assignment.

We compile, submit and follow up price and reimbursement applications and renewals in Finland. We take care of your Quarterly reference price notifications in Finland.

Translations management and coordination  

Good product information is critical to your product. We know local languages and requirements  to ensure your product information fulfils high quality standards. 

Our translations are always quality controlled (QC) by following four-eyes principle, according to given timelines, including linguistic reviews, updates, and inclusion of local information. Approved vendors may be used for translations, QC by our own staff is always included in service.  

We translate all product related, or process related documents, such as product information texts of various products, medicines, food supplements, medical devices, cosmetics. We translate also marketing materials, medical information questions, Adverse event reports, complaints, safety notifications, from English to local language or from local language to English.  

We translate and localize your SOP’s, forms, trackers or other documents for PV, GDP, GMP among others.  

In case of localisation of text in addition to translation; local requirements of product categories are always considered.

RA intelligence 

We keep you updated on local legislation changes, but in addition to that, you will be provided with news, and hints of coming changes in our territory. Feel free to choose product categories (Medicines, food supplements, medical devices, cosmetics), types of news PV, RA, GMP, GDP, clinical trials) and we will provide to you a monthly overview of what is going on.

Training

We ensure your message goes through and adjust to local requirements or responding to an expert confirmation.

Ask for annual PV, GDP refreshers, process specific trainings, such as trainings on deviations, changes controls, pharmacovigilance case management or whatever knowledge in the need to be known more.  

Contact Us