Pharmaceuticals

We support businesses across the pharmaceutical value chain to assess risks, understand impacts, and evaluate the maturity of their responsible sourcing practices. Our approach combines proprietary data analytics with systematic verification methodologies, delivering thorough yet pragmatic due diligence tailored to your business needs and regulatory requirements.

• Support pharmaceutical companies to assess risks, impacts, and the maturity of responsible business practices across API sourcing, excipient procurement, and manufacturing operations
• Deliver pragmatic, ESG-focused due diligence informed by extensive on-the-ground experience across pharmaceutical manufacturing, API production, and medical device supply chains
• Provide clear, tailored reporting aligned with business and stakeholder needs
• Help pharmaceutical manufacturers identify and mitigate human rights, social, and environmental risks linked to suppliers and sub-tier API producers
• Conduct supplier due diligence for CMOs, API manufacturers, excipient suppliers, and packaging producers against industry standards and responsible sourcing frameworks
• Support investors and financiers in assessing ESG and human rights risks in pharmaceutical transactions and M&A
• Enable pharmaceutical companies to understand and manage ESG risks arising from procurement activities across complex, multi-tier supply chains

We are regularly asked to produce insight reports and data-driven research and analysis for a wide range of clients.

Our expert team of responsible sourcing specialists and data analysts have access to granular, facility-level risk data which can help teams with:

• Informed decision making on complex topics covering API production regions, manufacturing hubs, and raw material sourcing areas globally
• Legislation gap analysis to support internal audit programs and help your audit team understand the most likely areas of non-conformance with regulations like the German Supply Chain Act, CSDDD, and emerging pharmaceutical supply chain transparency requirements
• Develop risk assessments and opportunities for global pharmaceutical companies' responsible sourcing programmes
• Develop bespoke supplier reports for your teams to understand potential risks, opportunities, and gap assessments against your expected standards and industry codes of conduct
• Chemical and raw material specific risk assessments for critical pharmaceutical inputs

• Benchmarking and Maturity Assessment - We benchmark management systems and operating practices against compliance frameworks and pharmaceutical industry standards. Our deep data insights platform assesses current performance and identifies priority improvements across API sourcing, manufacturing, and quality systems.
• Management System Design and Implementation - We design and implement management systems for responsible business conduct and supply chain due diligence. This covers core governance such as policies, procedures, and risk assessment processes, then extends to supplier qualification protocols and API traceability systems. We also build in environmental management for pharmaceutical waste and reporting to meet regulatory requirements like the German Supply Chain Act and CSDDD.
• Audit Preparation and Corrective Action Support - We prepare pharmaceutical manufacturers, CMOs, and API producers for audits against industry standards, assurance frameworks, and regulatory requirements. Our support includes gap assessments, documentation development, staff training, and implementing corrective actions from previous audits.

Supplier Due Diligence Assessments - We deliver independent due diligence assessments of API manufacturers, excipient suppliers, CMOs, packaging suppliers, and raw material producers against HRDD requirements and industry standards. Our assessments include:

• Red flag evaluations against serious abuses including forced labour, unsafe working conditions, and environmental contamination
• Sub-national risk classification using our proprietary risk assessment framework, revealing facility-level and district-level risk variation that national classifications miss
• Supply chain traceability verification and documentation review across multi-tier API and excipient supply chains
• Stakeholder impact assessments including worker voice and community engagement
• Environmental risk assessments specific to pharmaceutical manufacturing (wastewater, chemical handling, pharmaceutical waste)
• Clear gap analysis and corrective action recommendations

• Salient ESG issue identification specific to pharmaceutical product categories and API portfolios
• Comprehensive human rights and environmental risk profiling for sourcing regions and manufacturing locations
• API supply chain concentration and diversification risk analysis
• Environmental impact assessments for pharmaceutical manufacturing and waste management
• Water usage and wastewater treatment risk assessments
• Chemical handling and occupational health risk profiling
• Historical legacy issues and reputational exposure assessments
• Community relations vulnerabilities around manufacturing sites
• Labour rights conditions including contract workers, laboratory staff, and manufacturing personnel
• Clinical trial ethics and patient safety considerations in global research operations
• Risk integration into sourcing decisions and supplier qualification processes
• Anti-corruption and bribery risk assessments across distribution and procurement

Crafting and implementing a robust human rights strategy is complex, encompassing sustainable development, worker safety, and mitigation of negative impacts. It must also weigh environmental impacts, from pharmaceutical contamination of water systems and chemical pollution through to hazardous waste management and occupational health risks.

A Human Rights Impact Assessment (HRIA) can help a pharmaceutical company assess and address the legal requirements relating to its existing or potential human rights impacts and meet its responsibility to address all human rights across its extended supply chains, from raw material extraction through API production, manufacturing, and distribution to healthcare delivery.

Aseri can help you determine if the specific human rights issues that affect your company are covered by other impact assessments or due diligence processes, and whether they require a separate HRIA, ensuring compliance with sustainable business regulations and maintaining the highest standards of patient safety and ethical conduct.

We deliver awareness raising and training for procurement and sourcing teams to better understand risks, then build internal audit capacity through to full audit training. Our auditors are accredited to the highest standards including ISO 14001, 45001, APSCA CSCA and have conducted thousands of audits globally. We can:

• Train your team in the environmental, social and governance issues present in pharmaceutical supply chains, and how to identify and mitigate risk across API sourcing, manufacturing, and distribution
• Help your team to implement any improvement actions needed to close the gaps identified during audits and assessments
• Provide the tools to improve operations in line with international and recognised standards and regulations, developing long-term internal capacity
• Build supplier capability to meet pharmaceutical industry standards and improve working conditions throughout manufacturing supply chains
• Deliver specialised training on pharmaceutical-specific risks including chemical safety, environmental compliance, API traceability, and anti-corruption measures