The cost of non-compliance for a pharmaceutical or medical device manufacturer can be crippling to the business. ESI can help mitigate the risks of regulatory audits by providing assessments and recommendations on all aspects of the product life cycle, from development and regulatory submissions to manufacturing and packaging processes.
ESI has helped companies proactively prepare for inspections through pre-approval inspection and FDA readiness audits, NDA/ANDA technical reviews and cGMP trainings to ensure key personnel are prepared for audit scenarios.
While an ounce of prevention is worth a pound of cure, companies can find themselves performing critical assessments of Quality Systems after a 483 or warning letter which can be costly and stressful. ESI can provide regulatory response strategies and serve as a liaison to the FDA field and headquarters offices.
Our team has many years’ experience in regulated manufacturing environments and specializes in developing corrective action plans that are able to meet compliance expectations but balance the business needs of the organization. ESI can also support organizations by performing batch record and lab data review and release during remediation of affected business units, which can allow for businesses to continue manufacturing while having core employees focused on remediation.