Post updated: November 2020. Starting on 1 July 2019, the Bulgarian Drug …
PharmDedict offer regulatory affairs support services in Bulgaria and Romania for pharmaceutical products, herbal medicines, medical devices, food supplements and cosmetics. For pan-European projects we rely on our partnership with and support by competent regulatory consultancy companies within the EuDRAcon network which we joined in 2010.
Marketing authorisations. Our services include strategic regulatory planning according to client’s needs efficiently in pace with planned market launch. We provide full range of services related to pre- and post-submission issues, follow up and communication with healthcare authorities as follows:
– Regulatory submissions under national authorisation procedures;
– National phase completion for MRP/DCP;
– Post-marketing applications and marketing authorisation (MA) maintenance support – variations, renewals, MA transfers;
– Regulatory documentation assessment and upgrade;
– Compilation of quality, non-clinical and clinical overviews;
– Readability testing of package leaflets.
Advice and assistance with local authorisation/notification procedures: advertising and promotional materials, educational materials, direct healthcare professional communication (DHPC).
We can also provide local representation and assistance in relation to:
– Medical devices notifications;
– Food supplements notifications;
– Cosmetic products;
– Translation and adaptation of the local labelling and leaflet in compliance with the relevant requirements.
For pharmaceutical products we also provide support for pricing and reimbursement:
– Advice on local pricing and reimbursement issues and avoiding the pitfalls of the national external and internal reference systems;
– Preparation of price approval and positive drug list applications;
– Translation of all related documentation;
– Timely follow up and communication with experts and administrative support at all levels.
We are currently expanding our regulatory expertise for Russia and other CIS countries, as well as selected MENA markets via partnerships with qualified external experts.
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