Services
BioMedical Centrum provides adequate support for domestic and international companies (manufacturers and distributors) in various scientific and professional fields:
Regulatory Affairs and Consulting
Medicines
- Preparation, revise of dossiers, documentations
- National procedures
- Decentralized procedures (DCP), mutual recognition procedures (MRP)
- Renewals, variations
- Common Technical Document (CTD) preparation
- Translation, adaptation of product information (SmPC, PIL, label texts)
- Application for price reimbursement
- Contact with authorities
- Consultancy
Medical devices and durable medical equipments
- Registration, approvals
- Translation, adaptation and checking of label text and instruction for use
- Preparation of clinical documentation
- Classification into categories
Paramedical products, PARNUTs (food for special nutritional needs), food supplements, cosmetics
- Notification, registration
- Preparation, revise of dossiers
- Translation, adaptation and checking of label text and instruction for use
- Statements related to health
- Adaptation of table of nutritional values (Nutrition Facts)
- etc.
Preparation/proofreading of literature and clinical descriptions or summaries
Preparation of expert opinions/judgments
The staff of BioMedical Centrum undertake on demand:
Scientific educations or trainings
(e.g. regarding active substance of the product)
Scientific lectures
(e.g. regarding active substance of the product or device)
In cooperation with our partners our services include:
Clinical trials
- Regulatory Affairs
- Feasibility and site selection
- Clinical monitoring
- Local project management
Pharmacovigilance
- Local contact to Pharmacovigilance Department of the Regulatory Authority
- Submission of PSURs, line listings, and local SUSAR reports
- Submission of RMPs
- Collection of adverse events from local literature
- Collection of ICSRs / documentation
- AE follow-up
- PV training for clients' personnel
- Regulatory Authority's communication
- Reconciliation report
Distribution
Recently, a new activity has been added to our portfolio. The years of experience have estabilished and built the foundation of the capability of developing our own products and introducing them in the Hungarian market. Read more >>>
Anthropological consultancy
Within the framework of a very special service area of BioMedical Centrum, the company undertakes anthropological researches, as well. The qualified biologist-anthropologists undertake classical anthropological and paleopathological processing and analysis on archeological excavations.
Lead researcher: Dr. Tamás Hajdu PhD, Assist. Professor
Department of Biological Anthropology
Eötvös University
Hungarian Natural History Museum
Phone: +36-70/591-93-16