Toxicological studies (PDEs, OELs etc.)

Our consulting services specialize in delivering thorough toxicological studies, including the development of essential reports like Permitted Daily Exposure (PDE) and Occupational Exposure Limit (OEL) reports. These reports are pivotal in assessing and managing potential risks associated with chemicals and pharmaceutical products. With our expertise, we ensure that your organization receives comprehensive, accurate, and compliant toxicological assessments to support safe and informed decision-making in your industry.

Clinical and non-clinical overviews (ACOs)

At SustChem, we understand that success in today’s healthcare landscape hinges on staying ahead of the curve. That’s why we specialize in Addendum Clinical Overview (ACO) services. Our team of seasoned experts possesses an in-depth understanding of the intricacies involved in ACOs, enabling us to provide tailored solutions that drive better patient outcomes and optimize healthcare resources. Whether you’re navigating regulatory changes, enhancing care coordination, or improving data-driven decision-making, our ACO expertise is your trusted resource. With our guidance, you can confidently adapt to evolving healthcare standards and excel in delivering high-quality, cost-effective care to your patients.

Risk Management Plan (RMP)

Companies seeking a fresh Marketing Authorization, there might be a requirement to present a Risk Management Plan (RMP). This is an inherent aspect of the comprehensive global pharmacovigilance solution offered by our expertise team. Over time, we will monitor the necessity for RMP updates and handle the entire process for our clients, including the preparation of any related changes.

Periodic Safety Update Reports (PSURs)

Periodic Safety Update Reports (PSURs) represent a cornerstone in the pharmacovigilance landscape, serving as meticulous assessments of a pharmaceutical product’s safety profile over time. These structured and regulatory-mandated documents compile a thorough analysis of adverse events, emerging risks, and benefit-risk evaluations associated with a drug throughout its lifecycle. Our team of experienced professionals excels in crafting PSURs that adhere to rigorous regulatory standards. Leveraging our expertise, we meticulously analyze diverse data sources, including clinical trials and post-market surveillance, to provide a comprehensive overview of the product’s safety landscape. Our PSURs not only ensure compliance with global regulatory requirements but also empower informed decision-making, fostering trust and confidence in the safety and efficacy of the pharmaceuticals we evaluate.

Environmental Risk Assessment

Environmental Risk Assessment (ERA) is a meticulous and indispensable process that evaluates potential risks posed by human activities, industrial processes, or substances to the environment. At Sustchem, we specialize in conducting comprehensive ERAs that adhere to the highest professional standards. Our approach involves a multidisciplinary analysis, considering factors such as environmental exposure, toxicity, and ecosystem vulnerability. We work closely with clients to identify, assess, and mitigate environmental risks effectively. Through our tailored assessments, we aim to foster sustainable practices, regulatory compliance, and a harmonious coexistence between industries and the environment. Trust us to navigate the complexities of environmental risk, ensuring a safer and more sustainable world for all.