Poland
Expert on Human Drugs & Biologics and Medical Devices
Agnieszka Buksowicz
Magdalena Czyzyk-Markiewicz
APC Instytut Sp. z o.o.
ul. Grójecka 22/24/lok 4
02-301 Warszawa
Phone: +48 22 668 68 23
Fax: +48 22 668 99 81
Email: ab@apcinstytut.pl; mo@apcinstytut.pl
Web: www.apcinstytut.pl |
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APC Instytut is the leader in the group of companies, which provide complex services for the Polish pharmaceutical market: Rx, OTC and Medical Devices. Since 1996, APC Instytut has been co-operating with national and international pharmaceutical companies. APC provides professional consulting services in the following areas: - Regulatory affairs (registration of Drugs, medical materials, food supplements, registration of clinical trials, lobbying etc.)
- Marketing management
- Outsourcing of medical representatives
- Recruitment and training
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Expert on Human Drugs & Biologics
AWAFARM is a pharmaceutical consultancy based in Poland providing a wide range of services including pharmaceutical product development and regulatory affairs support. AWAFARM's highly qualified experts can assist in all areas of registration process, evaluate the documents in view of current guidelines, prepare expert reports (Module 2) and manage either parts or the whole of your registration process: Mutual Recognition Procedure and Decentralised Procedure (MRP, DCP), National registrations, Centralised Procedure (CP), Variations and Renewals. We offer all aspects of training in regulatory affairs customised either as one-to-one tailored training, small groups or small seminars.
AWAFARM is also specialised in translating Summary of Product Characteristics, patient information leaflets (PILs), and pharmaceutical product labels into Polish or into English (Polish texts). We perform readability testing of PILs, which has been a legal requirement since 2005. We will ensure that the PIL follows the current QRD templates, the EC Readability Guideline, and all other related guidance for readability testing.
AWAFARM is situated in the centre of Warsaw not far from the Ministry of Health.