Gap Assessment and Remediation
Pharmaceutical Compliance Gap Analysis & Biotech Remediation
Gap Assessment & Remediation
Uncovering Risks. Closing Gaps. Strengthening Compliance.
In the highly regulated life sciences industry, even small compliance gaps can lead to significant delays, regulatory findings, or reputational harm. At Bionetwork Consulting, we specialize in conducting thorough Gap Assessments and leading effective Remediation efforts that help pharmaceutical, biotech, and medical device companies stay audit-ready and aligned with global standards.
Whether preparing for an inspection, launching a new program, or responding to a regulatory finding, our consultants bring a structured, risk-based approach to identifying and closing compliance gaps—without disrupting operations.
Identifying Gaps and Delivering Effective Remediation Solutions
Our Services Include:
Comprehensive Gap Assessments
Evaluation of systems, processes, documentation, and operations against applicable regulations (FDA, EMA, MHRA), GxP guidelines, ISO standards, and internal SOPs.
Regulatory Readiness Reviews
Mock inspections and pre-audit assessments to uncover weaknesses and prepare teams for agency engagement.
Audit Finding Response & CAPA Development
Expert support in interpreting inspection findings, crafting corrective and preventive actions (CAPAs), and communicating effectively with regulators.
Remediation Planning & Execution
End-to-end support in designing and implementing remediation plans—prioritized by risk, aligned with business timelines, and fully traceable.
