Regulatory affairs and clinical research outsourcing offers a number of advantages to pharmaceutical companies. This way a marketing authorisation holder or sponsor can convert the fixed costs of maintaining the personnel, expertise and facilities necessary for regulatory approval processes and clinical trial management into variable costs. Farchim-Pol’s full service in these fields includes: |
| • | Preparation, submission and care of marketing authorisation applications for medicinal products being registered in national or European procedures (DCP and MRP) |
| • | Review of SPC, PIL and Labelling documents for the Centralised Procedure |
| • | Preparation of dossiers in the CTD format |
| • | Preparation of dossiers in the eCTD format (as the first company in Poland) |
| • | Reformatting old NTA dossiers to the CTD/eCTD format |
| • | Ordering stability tests in reputable Polish laboratories |
| • | Pharmacovigilance service for international marketing authorisation holders having no local safety unit which is mandatory according to the Polish law |
| • | Organisation of clinical trials in Poland, choosing the right sites, patient monitoring and all regulatory work to support clinical trial applications in Poland. |
| • | Preparation, submission and monitoring of marketing authorisation and renewal applications for medical devices (CE certification) and biocidal products |
| • | Organisation of the product manufacturing in Poland |
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If needed, Farchim-Pol has a marketing authorisation holder license for Poland.
We have been active on the Polish market since 1996. Our clients (i.e. Abbott, Bio-Diät, Coloplast, Dr. Klein, Fresenius Kabi, Genzyme, Hospira, Octapharma, Pfizer, SmithKline Beecham, Thor, Torrex Pharma and numerous Polish companies) rely upon our expertise and experience. |
