Regulatory Basis

The Regulatory Basis pages are dedicated to the regulations and standards applicable to the pharmaceutical and biotechnology industries that are issued by regulatory agencies (FDA, ICH, Health Canada, EMEA). For your convenience the documents are organized by category.

The extremely versatile Warning Letter database contains selected and carefully processed FDA Warning Letters published since 1996. These can be a beneficial source of information to those companies that are preparing to undergo inspection. Additionally, the Warning Letters enable the preparation of case studies, interpretation of the rules and regulations, investigation practices within companies, recognizing the prevailing trends of authorities requirements.
The database will assist you to make either a simple or an advanced search based on our unique data processing methods. You can also make free text search within the contents of Warning Letters. The search results obtained are summarized into a table. Displayed data comprises the name and address of companies, duration of inspection, inspector name, cited regulations, etc. Naturally, the Warning Letter(s) you select can be downloaded or printed.