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ANALYTICAL METHODS, PROCESS, CLEANING, AND COMPUTERIZED SYSTEMS VALIDATION

Of greater value than the expertise of a single individual, Pharmatech Associates offers the advantage of validation services that are methodology driven, based on a documented, structured and analytical procedural map that evolves over time in response to changes in regulatory, scientific and business conditions. Constantly tested and upgraded, our methodology ensures a common defined practice, specific vocabulary and consistent results. Pharmatech’s approach is based on real-world industry experience and is tailored to your needs.

Our areas of expertise include the following:

  • Analytical Methods Development
  • Process Validation
  • Cleaning Validation
  • Computerized Systems Validation
  • Biotechnology and Cellular-based Processing
  • Biopharmaceutical Manufacturing
  • Bulk and Aseptic Fill/Finish
  • Active Pharmaceutical Ingredient (API) Production
  • Oral, Liquid and Semi-Solid Drug Manufacturing
  • Pulmonary and Transdermal Drug-Delivery Systems
  • Combination Products
  • Botanical Drugs
  • Nutritional Supplements
  • Human Medical Diagnostics
  • Medical Device Operations

You may be interested in the following article:

A Comparative Framework Between New Product and Legacy Product Process Validation

This paper is a comparative analysis between the application of the FDA Process Validation Guidance (2011) to new products and legacy products.