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Anticipating FDA Initiatives for Risk Management

May 6th, 2015 by

Guidelines Rules and ComplianceRegulatory bodies like the FDA enact initiatives on a routine basis. While their timing [...] Read More

Defining Critical Quality Attributes in the Pharmaceutical Manufacturing Process

July 15th, 2014 by

Quality By DesignPharmaceutical firms that wish to create product lines and cater to consumers as reliably as possible must ensure that their products are of a consistently high enough quality to fulfill user needs. While certain post-production checks and assurances can aid in this area, many organizations find it far more helpful [...] Read More

Risk and Supply Chain Security – Meeting the Demand for Compliance

March 6th, 2014 by

Pharmaceutical Lab EquipmentCompanies which manufacture and distribute pharmaceuticals in domestic or international markets face more scrutiny than ever from regulating authorities, including the FDA and European Regulatory Authorities. Much of this scrutiny revolves around drug safety, also known as pharmacovigilance.

Appropriate and effective risk management and supply chain safety and security protocols are vital for FDA and EU compliance. There [...] Read More