46 CHEMICALS KNOWLEDGE HUB Issue 2 / October 2025 operational excellence” if they are to benefit from the next wave of outsourcing growth. 4 The message is that compliance is no longer a background function: it is a strategic investment priority. CordenPharma, for example, has committed €10m ($11m) to a new cGMP oral solid dosage facility in Plankstadt, Germany, while Carbogen Amcis is investing CHF 25.5m (€26m / $27m) to expand Swiss sites for ADC manufacturing. Both projects are framed not simply as capacity expansion but as quality-system upgrades, a recognition that, under FDA and EMA scrutiny, investment in compliance infrastructure is as vital to securing contracts as investment in new science. The FDA has underlined why such investment matters, stating in its data integrity guidance that it “expects that all data be reliable and accurate.” 5 The European Medicines Agency has echoed the point, tightening expectations on remote batch certification and oversight of outsourced operations. 6 Sponsors have taken note. A CDMO with spotless inspection histories and demonstrable investment in its quality infrastructure is now often worth more to a client than one offering marginally lower costs. In this environment, compliance spend is no longer optional overhead; it is the price of staying in the game. ESG as a core partnership criterion Yet compliance is no longer defined by regulators alone. Increasingly, it extends into how contractors manage their environmental footprint and labour standards. Sustainability has moved from a side note in procurement to a defining element of partner selection. Pharma groups are under mounting pressure to disclose supply-chain emissions and labour standards; obligations that now cascade down to their contractors and turn what was once a tick-box exercise into a material factor in long-term outsourcing agreements. For CDMOs, this has changed the conversation. Sponsors increasingly want to see emissions baselines, evidence of energy-efficiency programmes, and credible roadmaps to reduction targets. The most advanced providers are building sustainability metrics into their performance reviews, treating them as seriously as yield or ontime delivery. Investment is beginning to follow. PCI Pharma Services, for example, has introduced energyefficiency upgrades and recycling initiatives across its packaging sites, positioning them as both costsaving and compliance-driven. Packaging and logistics retrofits of this kind, site energy reductions, and supplier audits that extend into second- and third-tier networks are all becoming standard practice. Those that fail to keep pace risk exclusion from tenders, not because their science is lacking but because their disclosure is. The shift is not about image so much as risk. For a sponsor, the reputational cost of a partner found to be non-compliant with environmental or labour standards can be severe. In that sense, ESG has become another form of compliance, one that will increasingly determine who wins the most valuable contracts. Digitalisation driving trust and efficiency If sustainability is reshaping physical operations, digitalisation is transforming how those operations are monitored. The pandemic made clear that oversight no longer requires physical presence. Remote audits, once a stopgap, have become routine, with sponsors expecting contractors to provide real-time access to batch records, deviation logs and quality data. For CDMOs, digital capability is now as critical as physical capacity. One European CDMO recently completed a digital quality-management transformation that moved all documentation and training systems online, cutting approval and retrieval times by almost a third while strengthening audit readiness. These cases highlight how digital tools are not simply efficiency upgrades but foundations for regulatory trust. The most advanced providers are now experimenting with predictive maintenance, digital twins and integrated dashboards, allowing clients to interrogate live data rather than wait for retrospective reports. Others are still climbing the ladder, moving from paper to basic electronic systems. That gap is becoming more visible as sponsors demand evidence of a digital roadmap alongside proof of ESG performance and regulatory compliance. CONTRACT SERVICES
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