RegWise Solutions
Safety first, science always,
RegWise Solutions freeze any doubts!
We are a young team of risk assessors specialized in regulatory toxicology with 4 years of experience in deriving Permitted Daily Exposures (PDEs)/Acceptable Daily Exposure (ADEs) and Occupational Exposure Levels (OELs).
RegWise Solutions
Highest scientific and regulatory standards
Our work is fueled by a strong passion for toxicology. Our professional experience has focused primarily on establishing health-based exposure limits (HBELs) for drugs produced in shared facilities, as well as assessing the associated health risks for workers. At Wise Regulatory Solutions, we pride ourselves on providing high-quality PDE/OEL reports that adhere to the highest scientific and regulatory standards. Here are some of the strengths that differentiate us from other providers:
Human Data-Driven Approach for Accurate PoD Selection:
At Wise Regulatory Solutions, we prioritize the use of human clinical data when selecting the point of departure (PoD) for health-based exposure limits (HBEL). While animal data can provide valuable insights, we recognize that human data often presents the most accurate reflection of potential adverse effects. As the EMA guidance suggests, when the critical effects are pharmacological or toxicological effects observed in humans, we use substance-specific clinical assessments to ensure the PoD is as relevant and protective as possible for human health.
Balanced and Justified Use of F factors
Our team of experienced professionals applies a methodical approach when using F factors and adjustment factors. We understand that excessive use of these factors can signal a lack of understanding or missing data. That’s why we carefully assess each factor and apply them only when scientifically justified. This ensures that the final product is robust and reliable, without relying on exaggerated mathematical results that could compromise the validity of the report.
Scientifically Supported Statements with Full Citations
At Wise Regulatory Solutions, we uphold the integrity of every report we produce. Every scientific statement is backed by reliable, peer-reviewed data, and all sources are thoroughly cited. Our commitment to transparency ensures that the conclusions we present are always credible and scientifically sound.
Credible, Primary Data Sources for Robust Reports
We never rely on safety data sheets (SDS) as the primary source of information. While SDSs may offer some context, they are often incomplete or lacking in supporting data. Instead, we use reliable, peer-reviewed scientific studies and data directly related to your specific compound, ensuring that our reports are based on the most accurate and comprehensive information available.
Comprehensive and Valuable Reports—No Filler
We believe that the value of a PDE report lies in its content, not in unnecessary additions. Our reports are concise, focused, and content-rich, providing clear and actionable insights without unnecessary filler material. You won’t find lengthy, irrelevant tables or excessive margins with logos and CVs. Our focus is on delivering high-quality, scientifically rigorous documentation that directly addresses your needs.
Clear, Transparent Reporting with No Hidden Costs
At Wise Regulatory Solutions, we understand the importance of clarity. That’s why we openly disclose the validity period of our reports. We are transparent about our pricing and report timelines before starting, helping you plan ahead without unexpected costs.
Highly Qualified Experts
The quality of our reports is directly tied to the expertise of our team. We employ professionals who are highly trained and experienced in regulatory science. This ensures that every report is prepared and reviewed by professionals who bring both deep knowledge and years of experience to the table, providing you with the highest level of assurance.
