Pharmaceutical due diligence involves a thorough investigation of various aspects of a pharmaceutical company or product before entering into a transaction or partnership. The requirements for pharma due diligence include:

Regulatory Compliance:

Licensing and Approvals: Verification that the company has all necessary regulatory approvals and licenses for their products and operations.
Compliance History: Review of past compliance issues, warning letters, and regulatory actions.
Intellectual Property (IP):

Patents: Analysis of the company's patent portfolio, including pending and granted patents.
Trademarks: Review of trademark registrations and potential infringements.
IP Agreements: Examination of licensing agreements, collaborations, and IP disputes.
Quality Systems:

ICH Q10 Compliance: Ensuring the company's pharmaceutical quality system meets the requirements outlined in ICH Q10, which includes:
Quality Management: Comprehensive documentation and implementation of quality management principles.
Product Realization: Processes from development to commercialization.
Continual Improvement: Mechanisms for ongoing improvement of processes.
Risk Management: Risk assessments and mitigation strategies for product quality.
Manufacturing and Supply Chain:

Manufacturing Processes: Evaluation of manufacturing processes and facilities for compliance with Good Manufacturing Practices (GMP).
Supply Chain: Assessment of the supply chain, including suppliers' quality and reliability.
Production Capacity: Analysis of production capacity and scalability.
Financial Due Diligence:

Financial Statements: Review of financial statements, audits, and financial health of the company.
Revenue Streams: Analysis of revenue streams, profitability, and market performance.
Cost Structure: Examination of cost structures and potential financial risks.
Market and Commercial Considerations:

Market Position: Evaluation of the company's market position, competitive landscape, and market share.
Sales and Marketing: Review of sales strategies, marketing plans, and distribution channels.
Product Pipeline: Assessment of the product pipeline, including development stage and potential market impact.
Legal and Contractual Issues:

Litigation: Review of ongoing and past litigation, legal disputes, and liabilities.
Contracts: Examination of key contracts, partnerships, and agreements.
Operational Due Diligence:

Management Team: Evaluation of the management team’s experience and track record.
Organizational Structure: Review of organizational structure, employee qualifications, and HR policies.
Operational Efficiency: Assessment of operational efficiency and processes.
The ICH Q10 guidelines, specifically, emphasize the importance of a comprehensive pharmaceutical quality system, which includes:

Management Responsibility: Leadership's commitment to quality and continuous improvement.
Quality Risk Management: Systematic process for the assessment, control, communication, and review of risks to quality.
Knowledge Management: Utilizing knowledge to improve product quality and ensure consistent performance.
Product Lifecycle Management: Integrating quality into every stage of the product lifecycle, from development to discontinuation.
These components ensure that the pharmaceutical quality system is robust, effective, and capable of maintaining product quality and compliance with regulatory requirements.