PharmAdvice Ltd - Your pharmaceutical consultant

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 manufacture / 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.

Pharmacovigilance, pharmacoepidemiology.

Consultations and expertise in clinical pharmacology and therapeutics, health economics, pharmacoeconomics.

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.

Drug Regulation: Advisory and expert in the field of drug regulation

Pre-submission activities:
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
• Decentralised Procedure
Participation in break-out sessions
Post marketing maintenance
Variations
Renewals

Advisory in drug policy: Pricing and reimbursement of medicinal products

Advisory and expert in the field of drug regulation
• Pricing and reimbursement of medicinal products
• Consulting-scientific, information and publishing activities in the field of national and European pharmaceutical legislation

Medical devices: Marketing of Medical Devices

Medical devices - advisory and expert activity
• Marketing of Medical Devices
• Clinical trials of medical devices
• Market surveillance , trade and safety (systems for notification and assessment of incidents) of medical devices

Lectures and training courses

• Drug regulation and drug policy
• Health Economics and pharmacoeconomics
• Good Clinical Practice
• Good Distribution Practice
• Good Pharmacy practice
• Pharmacovigilance, drug information and drug utilization

Scientific advice: Organization of specialized medical scientific activities

• Meetings, workshops, conferences, roundtables, workshops with journalists, advertising campaigns in the media
• PR, media agency, press conferences
• Develop, organize and conduct product campaigns
• Supporting corporate public relations, relations with institutions and organizations

Clinical trials: Consultation on Good Clinical Practice

Contacts

PharmAdvice
1463 Sofia, 54 Buzludja Str., fl. 3

Tel.: + 359 899 866 124
  + 359 886 120 718

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