Having the correct materials for the formulation and manufacture of drug products is crucial. But what happens if a supplier can no longer provide the needed product? Changing a supplier ...

Change of lot or extension of reference standard shelf-life is considered low risk and should be downgraded from prior-approval to being managed in the Pharmaceutical Quality System (PQS) only based ...

The market regulator has released the procedure to obtain approval for the proposed change in control of merchant bankers and bankers to an issue, according to a circular issued on August 10. This is ...

Ben Oram, technical director at Buckley Gray Yeoman, AJ100 Practice of the Year 2023, explained the real-world implications of statutory six-week suspensions while unavoidable design alterations were ...