We offer basic regulatory services, our services comprise amongst others e.g.:
Medicinal products registration services:
marketing authorisation applications for MRP and DCP procedures, management of the procedure, and marketing authorisation holdership for national procedures; obtaining marketing authorisation submissions of all applications of medicinal products to the the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP)
responses to requests for supplementary information (deficiency letters)
preparation, translation and adjustment of Patient Information Leaflets (PIL), SmPC (Summary of Product Characteristics), mock-ups to the requirements of JAZMP and according to newest QRD template (including Braille)
coordination of variation processes, renewal applications and line extension applications (CP, MRP, DCP, NP)
transfers of marketing authorisations to new holders
contacts with Health Authorities (JAZMP and MOH)
services related to imports, distribution and wholesaling
market entry strategy development: recomendation of strategies to effect earliest possible approval of regulatory applications
pricing and reimbursement services
We can assist you at all phases of your product’s life cycle and it is our common aim to launch your product and maintain your marketing authorities in a controlled manner.
We are continously updating and maintain your marketing authorisation documentation . This secures uninterrupted availability of your product and up-to-date product information for physicians and patients. Our company keep your marketing authorization documentation up-to-date.
We can also work flexibly at your office through our outsourcing services for 1-5 days a week offering you additional capacity, supplementary skills or substitute services.
Contact us to see how we can assist you in issues related to maintenance of your marketing authorisation documentation: