Signal Detection and Risk Management:

· Utilize advanced methodologies to detect signals of potential safety concerns and develop effective risk management strategies for your products.

Risk Evaluation and Mitigation Strategies (REMS):

· Develop and implement REMS programs to minimize risks associated with specific products, ensuring compliance with regulatory requirements.

Pharmacovigilance Audits and Inspections:

· Conduct internal pharmacovigilance audits to assess compliance, and support companies during regulatory inspections to ensure adherence to standards.

Post-Marketing Surveillance:

· Develop and implement REMS programs to minimize risks associated with specific products, ensuring compliance with regulatory requirements.

 Patient Support Programs and Risk Minimization Measures:

· Develop and implement patient support programs and risk minimization measures to enhance patient safety and compliance.

Regulatory Intelligence and Updates:

· Stay abreast of regulatory changes, providing proactive updates and guidance to ensure continuous compliance.