Regulatory Compliance

Minervate is dedicated to global regulatory compliance and has expertise in, but is not limited to, the following:

MHRA (Medicines and Healthcare products Regulatory Agency)

FDA (Food and Drug Administration)

EMA (European Medicines Agency)

HC (Health Canada)

ANVISA (Brazilian Health Regulatory Agency)

Quality Management Systems

Ensuring readiness and documentation alignment.

Managing ALCOA-based documentation lifecycle.

Identifying and mitigating compliance risks.

Controlling organizational changes effectively.

Qualifying and monitoring vendors.

Implementing competency-based GxP training.

Maintaining calibration and qualification.

Investigating nonconformances with root cause analysis.

Corrective and preventive action frameworks.

Regulated complaint handling with traceability.

Tracking KPIs for continuous improvement.

Ensuring proactive inspection preparation.