PFAS Regulatory Support

PFAS (per- and polyfluoroalkyl substances) have indeed become a global concern due to their persistence in the environment and potential health risks. Regulatory bodies worldwide are increasingly focusing on PFAS, leading to stricter regulations and a push for safer alternatives. The coming years are set to bring significant challenges for industries, particularly pharmaceuticals which must protect public health, including restrictions on manufacturing, use, and marketing of PFAS, impact on medicines availability, and the need for alternative solutions.

Navigating this complex and dynamic landscape will require collaboration, ongoing research, and a strong commitment to both human health and environmental safety.

In the absence of specific regulations, companies should proactively and transparently address potential risks related to their products and brand. Although there is no universal method for assessing and mitigating the risks that forever chemicals pose to product portfolios, we recommend the following framework universally adapted to nearly any situation:

• Evaluate the potential effects of existing and upcoming regulations:
  Pharmaceutical companies should establish a proactive risk-sensing strategy to monitor regulatory changes and their potential impact on their products. This strategy should define the criteria for initiating a formal risk-management program assessing the necessary adjustments if certain substances could be banned by regulators. Can the product be reformulated without the prohibited ingredient or chemical? What would be the implications for the supply chain and patients?
• Product Assessment:
  Companies should identify any chemicals of concern in their starting material and finished products and evaluate potential exposure from manufacturing processes, upstream suppliers, equipment, and packaging. Reformulating a pharmaceutical product can be a lengthy and expensive process so understanding alternative compounds and their impact on availability, cost, efficacy, feasibility, and safety is crucial.
• Develop a proactive risk-mitigation plan:
  A risk-mitigation plan can serve as a safeguard if certain compounds are restricted. This plan should include identifying alternative supplies and suppliers. Remediating products and processes can be time-consuming and costly, extending beyond regular business operations so companies should create protocols for addressing regulatory inquiries to maintain trust and confidence if a formulation change is necessary.
• Testing & Confirmatory testing similar to nitrosamines

Stay ahead of the curve with our consultancy services! We offer expert guidance to help pharmaceutical companies navigate the complex landscape of PFAS regulations.

Our services include:

• Risk Assessment and Management:
  Our team conducts thorough risk assessments to identify potential PFAS-related risks in your products and processes. We then develop and implement risk management strategies to mitigate these risks.
• Alternative Solutions Evaluation:
  We assist in evaluating alternative compounds and materials, ensuring minimal disruption to your supply chain and product efficacy.
• Regulatory Documentation and Reporting:
  We prepare and manage all necessary documentation and reports required by regulatory bodies, ensuring timely and accurate submissions.

Together, we can address this global emergency and contribute to a safer, healthier future.