Resources

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...

Leveraging Process Analytical Technology for CMC Introduction In the evolving field of pharmaceutical development, the implementation of Process Analytical Technology (PAT) for manufacturing is an essential competitive advantage. PAT offers...

The world has changed in many ways since the outbreak of the global COVID-19 pandemic. Regulators are taking advantage of technology to institute greater social distancing, limiting contact between people...