Regulators
Quality systems: effective delivery of compliance
Effective regulatory quality and compliance processes are vital to maintaining shareholder value. Commercial risks escalate as strained infrastructures struggle to assure compliance. Controlling these profound commercial risks require effective initiatives to keep pace with regulatory scrutiny.
PA helps clients implement and deliver strategies and initiatives for pharmaceutical, medical device, immune diagnostics and biotechnology organisations, including:
- deliver and implement corporate quality system strategy
- catalogue and resolve compliance exposure and business risks
- manage FDA 483 / Warning Letter Remediation
- quality system, IP and operations M&A due diligence
- pharmaceutical process and PAT development in dedicated GMP / GLP facilities.
- Lean Six Sigma optimisation and process quantification
- optimise quality system and CAPA system performance
- independent quality management system IT Implementation and assessment
- align QMS, ESP, MES, MCP with QSR, ISO13485, 21 CFR Part 11, 210, 211,
- commercial and healthcare personalised medicine implementation
Further information
For further information please e-mail: healthcare@paconsulting.com
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