Regulatory Compliance Featured Articles

  1. Mapping Strategy Fundamentals For Regulatory Compliance

    In order to comply with regulatory mandates in the manufacture of pharmaceuticals, you need a mapping strategy several reasons. 

  2. Making Sense Of Sensor Numbers And Placement

    There are many factors that are in play for the number of sensors required. It would be nice if there was a simple formula such as one sensor per square foot or per square meter.

  3. Monitoring Mistakes: Avoid The Most Common Mapping Issues

    In spite of the headline, it is difficult to pin point the one single most common mistake. This articles focuses on what not to do, or what to avoid, during the mapping process.

  4. What Does "Child Resistant Packaging" Mean In Pharma?

    Child resistant packaging intergrates the use of safety mechanisms and physical barriers to reduce the risk of poisining in children via the ingestion of potentially hazardous medicines.

  5. Navigating The Marketing Authorization Process In Europe

    To be able to market a medicinal product in Europe, you must obtain a Marketing Authorization (MA) from the relevant regulatory authority. There are a number of different routes to apply for an MA.

  6. Phase II And Phase III Studies Standard Protocol A Template For Success?

    The ultimate goal of a template is to help investigators create high quality protocols that are consistent, well organized and contain all pertinent information needed to be properly reviewed.

  7. Insight Driven Formulations Development

    A considerable amount and variety of data is generated during the process of optimizing the formulation of a novel therapeutic. A consistent approach to managing this information is critical.

  8. Incorporate Data Integrity Into Your Pharma Quality Management System

    A viable QMS cannot be based upon anything except data and records that are attributable, legible, contemporaneous, original, accurate, complete and easily retrievable. 

  9. Managing GxP Environmental Systems To Ensure Data Integrity

    In the life science industries — pharma research, manufacturing, medical devices and biotech — guidance and regulatory enforcement strategies are being re-evaluated with a focus on data integrity.

  10. Perfect Potent API Processing: Handling Hazardous Drug Actives Effectively

    The journey from discovery to pharmacy is long and arduous, particularly for highly potent APIs, which must be handled in compliance with complex regulatory requirements at each stage.