- Identifying of new API manufacturers – The selection of
API manufacturer is done through a stringent qualification process and
capability assessment. Each stage of the project is critically
monitored and unabridged communications in the form of reports by our
partners experts are made available to both the parties. Any API's are supplied
together with the complete documentation needed for registration (GMP,
DMF in CTD format, etc.)
- Evaluation and development of new API's - QPS, through our
partners, are developing and providing alternative low-cost sources for
off-patent molecules thus offering a competitive cost advantage and
longer life cycle to the finished generic candidates. The decision of
developing a certain API is based on thourough patents and regulatory
checkings and assesments and on market research reports, enbling the
creation of a patent non-infringing API. The API newly developed will
be accompanied with the full documentation needed for registration (GMP,
DMF in CTD format, etc.). This activity may give to a generics
pharmaceutical manufacturer the unique oportunity to own the exclusive
API development, which may further lead to a time advantage first
launch on the market and to a cost-effective development.
- Compilation of the Drug Master Files (DMF's) for the
API's in CTD/eCTD format - In direct accordance with the rules and
regulations of the European and local authorities in Romania, QPS
provides, trough our partners, the service of compilation of the DMF in CTD/eCTD format for
API’s, upon customer’s firm request.
- GMP auditing of the API and / or finished formulation
facilities - GMP auditing of any kind of facility related to
pharmaceutical and / or cosmetics industry is a service which is
provided by QPS, though our highly specialized and experienced
collaborators and partners.
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