Intro
PharmAdvice Ltd provides:
Drug Regulation: Advisory and expertise in the field of drug regulation
• Development strategy and planning
• Scientific advice from authorities
• Evaluation / Review of documentation
• Preparation of reports
Marketing Authorisations
• Applications, Regulatory strategy, Documentation in NeeS format, Summaries and overviews, Expert statements, Application form, Product information (incl. translations)
• Summary of Product Characteristics
• Labelling
• Package leaflet
Submission to authorities
• National Procedure
• Mutual Recognition Procedure (MRP)
• Decentralised Procedure (DCP)
• Participation in break-out sessions
Post marketing maintenance
• Variations
• Renewals
Advisory in drug policy: Pricing and reimbursement of medicinal products
• Pricing and reimbursement of medicinal products
• Consulting-scientific, information and publishing activities in the field of national and European pharmaceutical legislation
• Budget Impact Analysis
• Evaluation of the quality, efficacy and safety of medicinal products in relation to marketing authorization or registration.
• Advisory and expert activities in procedures for issuing authorization to manufacturer / import of medicinal products, Good Manufacturing Practice, Management Systems and Quality.
• Parallel imports of pharmaceutical products, wholesaler in medicinal products, Good Distribution Practice and retail sale of medicinal products.
• Advertising of medicinal products, drug information and drug promotion.
• Consultations and expertise in clinical pharmacology and therapeutics, health economics, pharmacoeconomics.
Pharmacovigilance
• Aggregate Report Writing
• EU-QPPV/Local-QPPV (certified in Eudravigilance (ICSR and XEVMPD)
• ICSR, Signalling and Risk Management
• Risk Management Plans
• PSURs
• Literature Surveillance
About
PharmAdvice Ltd
is a limited liability company registered in the commercial register of the Registry Agency with business activity "advice in the field of drug regulation and drug policy, training, internal and external economic activity, manufacturing activity, trade representation, brokering, agency, provide services and all activities not prohibited by law."
PharmAdvice Ltd
has a staff of highly qualified experts and consultants with extensive experience in the field of drug regulation, drug policy, clinical pharmacology and therapy, and medical education. The majority of experts are senior lecturers in medical schools, holding academic degrees and titles, leading experts in scientific and practical achievements in the field of drug regulation.
Some of the key partners of the company are:
• Farmak-Bulgaria Limited.
• Farmak S.A Ukraine
• Neola Pharma
• ACCORD HEALTHCARE Limited.
• Rex Pharmaceuticals Limited. - Branch Bulgaria
• Boiron
• Майлан ЕООД
• Pharmascience International Limited.
• Алуфарма България ООД
• Warsaw Pharmaceutical Works POLFA S.A., Poland
• Pharmaceutical Works POLPHARMA S.A., Poland
• RECORDATI IRELAND Limited., Ireland
• Recordati Industria Chemica e Pharmaceutica SpA, Italy
• RECORDATI BULGARIA Limited., Bulgaria
Pharmacovigilance
Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. The European Medicines Agency (EMA) coordinates the European Union (EU) pharmacovigilance system and operates services and processes to support pharmacovigilance in the EU.
NOTIFICATION OF ADVERSE REACTIONS FROM NONPROFESSIONALS
NOTIFICATION OF ADVERSE REACTIONS FROM MEDICAL PROFESSIONALS PERSONS
PharmAdvice Ltd is responsible for the monitoring of the following Medicinal Products:
Amitrex / Амитрекс
Brelax / Брелакс
Clonareks / Клонарекс
Izoreks duomax / Изорекс дуомакс
Izoreks / Изорекс
Validol / Валидол
Calcium gluconate Farmak / Калциeв глюконат Фармак
Baclofen Pharmadvice / Баклофен Фармадвайс
Betaloc ZOK / Беталок ЗОК
Eligard / Елигард
Lomexin / Ломексин
UROREC / УРОРЕК
Our Team
Iva Aleksandrova Parvova-Hristova MD, PhD
General Manager
Areas of Expertise:
Clinical pharmacology, Internal diseases, Rheumatology, Clinical development, Medical affairs, Biological medicines and Biosimilars
Prof. Emil Hristov MD, PhD
Head of Regulatory Affairs
Areas of Expertise:
Clinical pharmacology and therapy, Internal diseases, Gastroenterology, Clinical development, Pharmaceutical legislation, Medical affairs, Pricing and reimbursement, Pharmacoeconomics
Petya Grueva MPharm, LLM EU
Senior Regulatory and Quality Assurance Lead
Areas of Expertise:
Regulatory and QA compliance, Medical writing, Pharmaceutical legislation
Stefka Stoyanova, MPharm, PhD
Regulatory and Pharmacovigilance expert, EU-QPPV
Areas of Expertise:
Medical Devices and Food supplements, Pharmacovigilance, Pharmaceutical care
Daniela Yordanova, MChem&Phys
Senior Regulatory and Pharmacovigilance expert, Deputy EU-QPPV
Areas of Expertise:
Dossier quality assessment, Serialisation and verification compliance, Pharmacovigilance
Emanuil Yodranov, MPharm, PhD
Regulatory Affairs Associate and Quality Assurance Deputy
Areas of Expertise:
Market Access, Pricing and Reimbursement, Serialisation and Verification Compliance, Pharmacoeconomics
Adverse Drug Reaction Report
Contact
PharmAdvice
1463 Sofia, 54 Buzludja Str., fl. 3