Systematic Remediation – Import Alert, WL, 483’s

We support the Pharmaceutical and Bio-pharmaceutical manufacturer in analysing the deficiencies observed by the regulators and responding them with enforced actions. We develop strategic plan to address the action, derive the solutions in a collaborative effort that targeted for practically compliant, achievable and fail proof quality system. It encompasses, but not limited to;

.  Assessment of the Warning letter/ Import ban of the Organization between the lines;

.  Gap analysis of the facility, quality system, product & process, analytics and knowledge;

.  Adequacy mapping of the quality attributes for effective investigation, RCA, Impact analysis, CAPA, and Change management;

.  Deployment of quality matrices, Quality Risk and Knowledge Management to bridge the gap appeared in the Warning letter/ Import ban;

.  Unit operation and hand-holding of the SMEs to ensure continual enrichment of system and practices by nurturing competency & Team spirit;

.  Support to response to the regulatory authority, prepare to face regulatory audit.