Toxicology Services and Risk Assessment Consulting

Empower your regulatory journey with DDReg’s Toxicology Solutions.

DDReg offers Toxicology and Risk Assessment Services and specializes in a broad spectrum of Regulatory Toxicology Consulting solutions designed to address complex safety and compliance challenges. Our scientific and regulatory experts bring deep technical expertise to ensure that your products meet international toxicological and pharmacological standards.

Toxicological evaluations are the processes critical to ensure the safety, efficacy, and compliance of pharmaceutical products,medical devices, and consumer goods. With an evolving regulatory landscape and growing scrutiny on the safety of active ingredients, excipients, impurities, and materials, having a comprehensive toxicological strategy is essential for success in global markets.

Why Choose DDReg for Toxicology and Risk Assessment Services?

Expert Knowledge and Technical Expertise
Our team of toxicology consultants have extensive experience in evaluating active pharmaceutical ingredients (APIs), excipients, impurities, and materials used in pharmaceuticals, medical devices, and consumer products. We leverage cutting-edge methodologies, including in silico tools, risk assessments, and international toxicological frameworks, to deliver robust solutions.

Tailored Toxicological Strategies
We understand that each product and target demographic have unique toxicological challenges. Our solutions are customized to provide actionable insights and risk management strategies that align with global regulatory guidelines, including ICH, ISO, GHS, and more.

End-to-End Support
From initial risk assessments to dossier submissions, DDReg offers comprehensive support throughout the product lifecycle. Our team stays updated with the latest regulatory changes to ensure your products meet evolving compliance standards.

Our Toxicological Services Portfolio Include:

Assessment of Tox sections of IND applications

Review/Due diligence of Tox data for finalizing phase I & II clinical trial designs

Toxicological justification/ Advisory to release clinical holds by the agency.

Benefit-risk assessment of Active Ingredients for Target Patient Demographics and Administration Routes.

Impurity qualification from toxicology perspective.

SME for impurity specification

ICH M7 Risk Evaluation and Impurity Qualification Framework

In Silico QSAR Analysis for Genotoxicity Assessment.

Assessment of Nitrosamine Risks and Establishment of Acceptable Intake Levels.

Assessment and Rationale for Proposed Limits on Excipients.

Extractable and Leachable (E&L) risk assessment

Biocompatibility Assessment Framework.

Development of Biocompatibility Study Protocols in Accordance with ISO 10993 and ISO 18562 Standards.

Toxicological evaluation of consumer products/ingredients

GHS classification

Safety Data Sheet (SDS) or Material Safety Data Sheet (MSDS) authoring

Permitted Daily Exposure (PDE) or Acceptable Daily Intake (ADE) for Cleaning Validation of APIs and Cleaning Agents.

Occupational Exposure Banding (OEB)/Occupational Health Categorization (OHC) Pharmaceutical Intermediates and Starting Materials.

Occupational Exposure Limit (OEL)

Environmental risk assessment (ERA) for generic pharmaceuticals and innovative products

Partner with DDReg for Toxicology Consulting Services

DDReg is your trusted partner in navigating the complexities of regulatory toxicology and pharmacology. Our commitment to precision, compliance, and innovation ensures that your products achieve regulatory approval and maintain safety standards throughout their lifecycle.

How can we help you?

Call us on:+1 (302) 601-2755