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Due Diligence Audits
Due Diligence Audits
Comprehensive Compliance & Risk Assessment for Acquisitions and Investments
At Isha’s GMP, we provide Due Diligence Audits to support pharmaceutical, biologic, medical device, and dietary supplement companies in evaluating technology, products, facilities, and businesses before acquisition or investment.
Why Conduct a Due Diligence Audit?
- Ensure regulatory compliance and minimize risks
- Identify gaps & deficiencies before acquisition
- Assess management capabilities & operational effectiveness
- Evaluate supply chain & product pipeline for long-term viability
- Address regulatory affairs requirements proactively
Our Due Diligence Audit Services:
Regulatory Compliance & Risk Assessment
- Comprehensive compliance evaluation of target organizations
- Identification of deficiencies & regulatory gaps
- Development of remediation plans
Management & Operations Assessment
- Evaluation of executive & management personnel capabilities
- Review of management controls & governance structures
Supply Chain & Product Pipeline Evaluation
- Assessment of product development pipelines
- Supply chain resilience & regulatory compliance checks
Regulatory Affairs Support
- Strategic advice on regulatory filings
- Evaluation & resolution of complex scientific & regulatory issues
Key Benefits of Isha’s Due Diligence Audits:
- Risk Reduction – Identify potential compliance issues before acquisition
- Informed Decision-Making – Gain deep insights into regulatory and operational health
- Seamless Integration – Ensure smooth transition post-acquisition
- Regulatory Confidence – Be prepared for FDA, EMA, and global regulatory bodies
Need Expert Due Diligence Support? Contact Isha’s GMP Today!