compliance remediation and immediate response
What is it – This formalised, structured three staged programme is designed to transition you from regulatory distress to regulatory compliance.
Who uses it – This programme can be tailored and scaled from a localised departmental (Departmental or Quality Manager) improvement project to a multi-site remediation programme (Departmental Director, Quality Director, Corporate Compliance).
What it is – This service provides timely independent review of a higher risk issues that have significant regulatory compliance or batch disposition impact (e.g media fill failure, multi-batch investigation, stability failure, out of specification investigation or significant environmental monitoring excursion). It provides the company enhanced confidence by ensuring a robust evaluation and scientifically justified next steps with a fresh eyes review.
Who uses it – Quality Director or Corporate Compliance
What it is – Generating a robust and risk based regulatory inspection response is critical to influencing the final regulatory outcome. A carefully prepared response can help ensure that the company takes sufficient action to address the regulatory concerns, while ensuring that the level of regulatory commitment does not elongate the remediation and Regulator communication phase. Early engagement with our consultants can provide input prior to generation of the draft response which can then be crafted into an appropriately worded commitment document which builds the confidence of the Regulator.
Who uses it – Site Director, Quality Director or Corporate Compliance