Regulatory Affairs and Pharmacovigilance Consultancy Services
My company is providing Regulatory Affairs and Pharmacovigilance Consultancy Service for herbal medicinal products, medicinal products, herbal biocidal products, food supplements and medical devices.
After more than 10 years experience in the pharmaceutical sector, I decided to start my own company in 2018.
Please find more information about my experience from my LinkedIn page.
Please get in touch when you would like to have additional information.
• Consulting on European Union (EU) and local legislation – Medicinal Products Act, Ethical Code • Communication with Republic of Estonia Agency of Medicines (Ravimiamet) • Preparation and assistance in submission of regulatory affairs applications (National, MRP, DCP procedures, Centrally Authorised products (CP) translations), including new applications, variations and renewals to Republic of Estonia Agency of Medicines • Post-authorisation support and marketing authorisation maintenance procedures • Translations and linguistic reviews of product information: Summary of Product Characteristics (SPC), Patient leaflets (PIL), labelling text • Management of local translations for submission to Republic of Estonia Agency of Medicines • Update and maintenance of product packaging in line with the marketing authorisation requirements and appropriate local legislation • Consulting and communication with Republic of Estonia Agency of Medicines regarding permissions for use foreign language packages in Estonia for medicines • Pharmacovigilance support: communication with Republic of Estonia Agency of Medicines, implementation and approval of local Risk Minimization Measures (RMM) and materials with Republic of Estonia Agency of Medicines • Submissions of clinical trial applications, amendments, PV reports to Republic of Estonia Agency of Medicines and Ethics Committees
• Biocidal Products registrations in European Union countries • Consulting on EU Biocidal Products Regulation (BPR) • Consulting on preparation of Biocidal Product's Safety Data Sheet's (SDS) • Preparation of product information, using instructions for biocidal products according to the requirements • Poison Centres Notification (CLP) dossier preparation in UCLID for hazardous mixtures, dossier submission via European Chemicals Agency (ECHA) Submission Portal for biocidal products • Unique Formula Identifier (UFI number) generation for biocides Experience with 13 European Health Boards with national approvals for biocidal products that requires approval during transitional period
• Food Supplement notifications to the Republic of Estonia Agriculture and Food Board (PTA)
• Consulting on legislation applicable for food supplements
• Preparing and updating food supplement's packages and product leaflets according to the requirements
• Food supplements product information translation from English to Estonian and Estonian to English
• Medical device notifications to Health Board (Terviseamet)
• Consulting on local legislation and European Union (EU) legislation
• Preparing and updating medical device's packages and product leaflets according to the requirements
• Medical device product information translation from English to Estonian and Estonian to English
The service provided by Eliis Henrikson was quick and very professional. You could tell me that there is no such thing, but with Eliis's support all the cases in Estonia were solved fast. No problems, no mistakes and always professional help. The workload was huge, I am not speaking about 1-2 products. It was a bunch of never ending changes for multilingual products, with complex composition.
Regulatory Affairs Manager in Baltics
Biocidal products, natural:
I have worked together with Eliis Henrikson at ExtraWize OÜ for more than a year now. Specifically we cooperate on an ongoing project that involves different biocide authorization procedures.
Eliis has shown a very high level of professionalism towards every aspect of work that she has done for us. Ranging from all round help with regulatory affairs matters to being in charge of very specific biocide product registrations in multiple EU countries. Furthermore as our products fall under a special transitional period within the EU Biocidal Products Regulation (BPR) then Eliis has really proven herself to know the details and nuances of this segment of the field.
Based on our experience together I can confidently give Eliis my highest recommendation and have no doubt that she can provide excellent meticulous support with any biocidal product related projects.