We specialize in

Designing solutions for Cells and Tissue Banks, medical entities, cosmetic and pharmaceutical companies;
Preparation of documentation for Cells and Tissue Banks for inspection in the light of the government licensing requirements;
Implementation and maintenance of international standards for tissue and cell banks;
Implementation of guidelines for the transport of biological material (both domestic and international, including the IATA guidelines for biological materials Category B - potentially infectious);

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GCP Renovation – Modernization of ICH E8 and Subsequent Renovation of ICH E6

“ICH is inviting public review and comment on a reflection paper on Good Clinical Practice (GCP) “Renovation”, …

FDA’s Draft Guidances for the calendar year 2017

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) has published a Guidance Agenda …

Agreement between the EEA Heads of Medicines Agencies and the Pharmaceutical Inspection Co-operation Scheme

The Heads of Medicines Agencies of the European Economic Area (EEA HMA) and the Pharmaceutical Inspection Co-operation Scheme …