Dr Stanley Ltd.  Zahlungsanträge für Arzneimittelregistrierung

REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS, CLINICAL TRIAL MANAGEMENT, DRUG SAFETY MONITORING (PHARMCOVIGILANCE)


About us

 Dr Stanley Ltd. and its fields of activity

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. Dr Stanley Ltd. (former name: Farchim-Pol) offers full service in these fields including:
• 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 phase 3 clinical trials in Poland, choosing the right sites, patient monitoring and all regulatory work to support clinical trial applications in Poland.
• Organisation of inexpensive bioavailability and bioequivalence studies in Poland to support applications for registration of generics in the European Union.
• Preparation, submission and monitoring of marketing authorisation and renewal applications for medical devices (CE certification) and biocidal products
• Organisation of product manufacturing in Poland

If needed, Dr Stanley Ltd. can act as Marketing Authorisation Holder in Poland and in other countires.

We have been active on the Polish market since 1996. Our clients (i.e. Pfizer, Genzyme (now Sanofi-Aventis), Abbott, Aspen Pharma, Fresenius Kabi, Hospira, SmithKline Beecham, Coloplast, Dr. Klein, Thor, Torrex Pharma Bio-Diät and numerous Polish companies) rely upon our expertise and experience.