Resources

Companies within the life sciences industry have been increasing their use of third parties to manage postmarket surveillance activities in recent years. If you are thinking about outsourcing some of...

When you scale your Design Controls appropriately to the complexity and size of your company, it makes it easier to manage the scope of everyday work needed to keep your...

Developing a crisis management playbook designed for the challenges of the pharmaceutical industry sector is vital to ensuring long term business continuity. Below are a few critical risk management elements...

One of the most crucial parts of running a business in the pharmaceutical or medical device industry is meeting the standards that will ensure your customers receive the highest-quality service....

Health Canada, Therapeutic Goods Administration (TGA), and Medicines & Healthcare Regulatory Agency (MHRA) recently launched an innovative, new pilot focused on Good Manufacturing Practices (GMP). The Single Inspection Program is...

Since the Pandemic became global in 2020, the FDA has been requesting documents from firms in advance of or in lieu of an inspection. This authority comes from the Federal...