Services

 

Elbo-Trade is specializing in the pharmaceutical and health care industry offering it’s customers cooperation opportunities and a wide range of services including the whole of transactions process from the identifying potential of the new partners to the final signature of the contract in accordance with customers procedures and expectations.

1. Partners, products and licensing

- contract negotiations with qualified partners on a national/global level
- co-marketing or co-promotion partners
- sell off a product or the enlargement of a portfolio (license-OFF, license-IN)
- enlargement of active substances (API) portfolio

2. Introduction of the medicinal product for human use on the market

- preliminary assessment of existing registration documentation ( dossier in CTD format)
- submission of documentation to the Registration Agency and monitoring of the registration process ( NA-National Application, MRP-Mutual Recognition Procedure, DCP-Decentralized Procedure, CP-Centralized Procedure)
- preparation of high quality of printed materials: preparation of Summary of Product Characteristic (SmPC), leaflet (PIL’s) and label(s) in Polish version
- nonclinical and clinical studies reports
- obtaining of marketing authorization
- parallel import license application

3. Introduction to the market of medical devices, biocides, dietary supplements, herbal medicines and cosmetics

- preparation of the application form for submission
- consultation and product classification
- biocide products
- borderline product form application

4. Pharmacovigilance system; Medical Incidents Reporting

- preparation and implementation of the pharmacovigilance system
- preparation of PSUR’s
- monitoring of pharmacovigilance

5. Product maintenance on the market

- preparation of the renewal documentation including printed materials
- re-registration process and monitoring
- expert report related to product license variations
- post-marketing requirements

6. Other services

- administrative and legal services required for entry of the company into the Polish market
(registration of the company, building of sales-network, contract negotiations)
- preparation of the Main Pharmaceutical Inspectorate application form for acceptance to start production and import
- preparation of the Ministry of Health application form for reimbursement
- managing of contracts ( contract of representation, contract of cooperation, contract of logistic services, buying and selling contracts)
- preparation of the card characteristics for chemical substances according to ,,Reach”
- obtaining professional opinions from leaders or Institutions
- audits (preliminary audit for consultancy, of individual parts of production process)
- GMP assessments
- user testing of Patient Information Leaflets (PILs)

7. Consulting

- information on regulatory requirements in Poland
- European Directives review and interpretation
- interpretation of European Guidance Documents and legislation
- paediatric medicine applications
-parallel import license applications
- feasibility and price studies
- market analyses
- healthcare system
- others