Activities

Major qualifications
Monitoring of clinical trials - (8 years of experience)

• Phase II – IV, BA/BE;
• logistics; Project management;
• Medical writing;
• Medical advisor;
• Legal expert on clinical trials in Bulgaria;
• Regulatory support on Bulgarian drug legislation regarding clinical trials.

Drug regulatory affairs - (20 years of experience)

• Regulatory policies directed to marketing authorisation procedures at the Bulgarian Drug Agency (DP and MRP and national procedures) and also
• consultants services at EMEA level where the Bulgarian language (SmPC and PIL) is needed;
• Advise on local requirements for national applications as well as MRP, decentralised and centralised (NCES, Variations, renewals);
• Provide intelligence on legislative changes ongoing and future) to local requirements;
• Prepare good quality translations where needed. In particular to translate packaging, artworks and SPCs and prepare local artworks.
• For centralised products to meet the EMEA translation timings.
• To submit and co-ordinate maintenance related to approved products as necessary (variations, renewals, PSURs).

Related to clinical trials

• Translate and forward any AEs received, directly to the Client by fax or e-mail;
• Translate and forward any communication to the Client, received from the regulatory authorities, which request safety evaluation or label changes;
• Forward PSURs to the regulatory authorities, adding any necessary cover letter or local SPC.

Intellectual properties for pharmaceuticals in Bulgaria

Outcome research