July 5, 2013

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Controlled Substance Compliance Services (CSCS)

Pharmaceutical companies routinely work with controlled substances, and must have adequate controls in place, to meet the legislative requirements of the countries in which they operate. Legislation is becoming increasingly complex as legislators attempt to keep up with a rapidly changing environment. Legislation exists at local, national and international levels to restrict the production, import/export, supply, use and possession of certain substances. This legislation has to be interpreted and transformed from legal wording into scientific nomenclature to be useful to R&D scientists, i.e. words into chemical structures.

The increasing externalization of R&D in the Pharmaceutical industry means that compounds are produced, stored and transported across a multiplicity of geographies.   It is imperative that Pharmaceutical companies have a clear, detailed and accurate understanding of the regulations in all regions in which they operate.  Pharmaceutical companies need to hold multiple licenses to conduct research across the field of controlled substances.  But it doesn’t stop at research; controlled substances can be found in all areas of a pharmaceutical company’s operations, including final products.

Currently no single source of global controlled substance knowledge has been identified; just the legislation itself or specific country / legislation-type databases/websites.

The CSCS will support a range of business processes including:-

  • Management of Internal Compound Collections - regular checks  are required to ensure controlled  substances are correctly flagged and managed;
  • Compound Shipping- to ensure that controlled substances are not inadvertently shipped within or between countries;
  • Compound Synthesis – to ensure that controlled substances are not inadvertently synthesized;
  • Compound Purchase – to ensure that controlled substances are not inadvertently purchased;