Whitepaper: Navigating ICH Q3E: Implications for Extractables and Leachables (E&L) Evaluation
Published Jan 07, 2026

Our clients develop life-changing therapies and technologies. They trust us to guide them through complex regulatory pathways with integrity, responsibility and care. DLRC becoming a Certified B Corporation™ makes that commitment measurable.
Our B Corp certification demonstrates that we meet verified standards of social and environmental performance, accountability and transparency. It places us within a global community of businesses committed to balancing profit with purpose.
This isn’t just a badge. It reflects who we are, what we value and the kind of company we want to be: for our employees, our clients, our communities and the patients who ultimately benefit from our work.
B Corporations (or B Corps) are companies certified by the non-profit B Lab for meeting high standards of social and environmental impact. To achieve certification, businesses must:
B Corps share a common goal: to use business as a force for good while delivering long-term, sustainable value.
As a global regulatory consultancy, DLRC partners with organisations bringing life-changing therapies and technologies to patients. Our work demands integrity and responsibility at every step.
B Corp certification formalises values already embedded in how we operate: ethical governance, transparent decision-making and prioritising long-term value for all stakeholders, including employees, clients, communities and the environment.
The B Impact Assessment gives us a clear, independent framework to assess how our everyday choices create positive impact, from how we support our teams to how we engage suppliers. Certification is not an endpoint. It’s a framework for continuous improvement.
“I want DLRC to be a business that is well run, provides unrivalled career opportunities for all staff,
and that supports the local community as well as giving exceptional service to staff to help bring
innovative medicines to the market. The B Corp framework just felt right and I am truly delighted
to join this community of businesses.” – Dianne Lee, CEO
Based on the B Impact Assessment, DLRC achieved an overall score of 93.4, exceeding the 80 points required for certification and well above the median score of 50.9 for businesses completing the assessment.
Our score reflects strong performance across all five impact areas: Governance, Workers, Community, Environment and Customers.

The B Impact Assessment is detailed and evidence-based. Working through it provided valuable insights into where we excel and where we can strengthen our impact further.
We learned the importance of applying the same rigour we bring to our regulatory work to areas such as coordinated data collection and consistent documentation across teams. We discovered value in formalising practices that were previously applied informally. We also identified specific opportunities in areas such as supplier due diligence, environmental baselining and the consistency of certain feedback mechanisms.
Achieving B Corp certification is an important milestone, but it marks the beginning, not the end, of our journey. We remain committed to making meaningful progress each year as we strengthen:
For clients, B Corp certification is more than a label; it demonstrates that DLRC is a trusted partner committed to high standards, transparency and long-term value creation. Our regulatory strategies are designed not only for compliance but for sustainable and ethical impact.
For our teams and communities, certification validates the principles we work by and reinforces that how we work is just as important as the outcomes we deliver.
Ultimately, for the patients who benefit from our clients’ innovations, this commitment ensures that purpose stays at the forefront. Every decision we make, from governance to environmental impact, supports the goal of enabling safe, effective therapies to reach those who need them most.
You can view DLRC’s official profile here

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