Фармкомплаенс - Агентство по фармаконадзору "Фармкомплаенс"

ACTIVITIES

We work with registered and non-registered medicinal products for both human and animal use.

PHARMACOVIGILANCE

Full outsourcing of the pharmacovigilance system. Outsourcing of individual pharmacovigilance processes.

REGISTRATION

Formation, submission and full support of the registration dossier. Conducting user testing of the leaflet.

AUDITS AND INSPECTIONS

Conducting audits of individual processes and the entire pharmacovigilance system. Preparation for audits and inspections. Accompanying inspections.

MEDICAL WRITING

PSMF, RMP, PBRER/PSUR, CT Protocol, Clinical/Pre-clinical Overviews, Investigator’s Brochure, DSUR.

TOP 6 PHARMACOVIGILANCE SERVICES

We provide a full range of pharmacovigilance services for all subjects of medicines circulation. Here are the most popular ones.

OUTSTAFFING AND CONSULTING

Provision of qualified employees – QPPVs, their deputies, contact persons, specialists and managers for pharmacovigilance with 24/7 access. Consulting services.

ORGANIZATION OF THE SYSTEM

Organization of a pharmacovigilance system from scratch and maintenance of the existing one. Building a quality management system (QMS), writing SOPs and other QMS documents.

SCREENING OF LEGISLATION

Daily screening of legislation. Providing regular reviews. Preparation of Impact Assessments/gap analysis for each specific client pharmacovigilance system.

PHARMACOVIGILANCE WRITING

Pharmacovigilance system master file – PSMF, periodic safety reports – PSUR/PBRER/DSUR regular and including as per Decision 1583, risk management plans (RMP) in EAEU/EU format and harmonization.

MONITORING OF LITERATURE

Weekly screening of literature sources for drug safety information. Evaluation of information, submission to authorized bodies.

ICSR PROCESSING

Collection, processing, analysis, submission of individual safety reports to authorized bodies, entering information into the client’s database. English-Russian translations.

EDUCATIONAL EVENTS

We provide training in pharmacovigilance, organize workshops and professional development programs. As part of our educational activities, we cooperate with leading universities and scientific organizations.

TRAINING PROGRAMS

Raising the professional level and obtaining new competencies necessary for work in the field of pharmacovigilance. Issuance of government documents.

SCHOOL OF PHARMACOVIGILANCE

Unique educational programs with the possibility of individual training for beginners and experienced specialists in the field of pharmacovigilance. Seminars and master classes.

CLASSES FOR STUDENTS

Lectures and classes for students within the discipline “Introduction to the specialty”. Popularization of pharmacovigilance issues among future specialists.

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BENEFITS OF OUTSOURCING

We provide quality services and guarantee compliance with deadlines. We value our reputation and adhere to the highest standards.

HIGH LEVEL PROFESSIONALS

Thorough knowledge of the subject, strict compliance with the law, tracking industry trends, guaranteeing an effective quality system.

EXTENSIVE EXPERIENCE

Successful work experience in international and Russian pharmaceutical companies, knowledge of legislation and standards, an extensive network of contacts in the industry and knowledge of the specifics of the market.

EFFICIENCY OF OUTSOURCING

Possibility of full or partial outsourcing of processes, high-quality services against the backdrop of a shortage of qualified personnel, provision of proven, effective solutions.

ФАРМКОМПЛАЕНС