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.
- 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
- 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
- preparation of the application form for submission
- consultation
and product classification
- biocide products
- borderline
product form application
- preparation and implementation of the pharmacovigilance system
-
preparation of PSUR’s
- monitoring of pharmacovigilance
- preparation of the renewal documentation including printed materials
- re-registration process and monitoring
- expert report related to
product license variations
- post-marketing requirements
- 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)
- 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