Toxicological Risk Assessment (TRA)

We offer comprehensive toxicological risk assessments (TRA) for medical devices and gas pathway devices, in alignment with ISO 10993 and ISO 18562 standards. TRA is a crucial step in evaluating the safety of chemical substances that may leach from device materials and come into contact with the body. Our expert team assesses potential risks based on exposure levels, toxicological data, and the duration of patient contact. We identify and quantify chemical constituents, evaluate systemic toxicity, and provide clear, evidence-based conclusions to support regulatory submissions. Our tailored TRA services ensure compliance, minimize delays, and safeguard patient health.

Biocompatibility Assessments (BEP & BER)

Biocompatibility assessments are crucial for ensuring the safety of medical devices intended for human use. Two key documents in this process are the Biocompatibility Evaluation Plan (BEP) and the Biocompatibility Evaluation Report (BER). The Biocompatibility Evaluation Plan outlines the product strategy and provides details on the approach taken to assess the safety of the medical device or gas pathway device. This plan helps identify and mitigate potential risks by considering factors such as the material of construction, configuration, composition, sterilization, cleaning, packaging details, physical and chemical characterization, and CMR substances. The Biocompatibility Evaluation Report (BER) is a detailed document that summarizes the results of the biocompatibility assessment, evaluating factors like manufacturing process residues, sterilization, cleaning procedures, and other aspects to ensure the device's safety and biocompatibility.

Stability Studies for Medical Devices

Stability studies for medical devices are essential to evaluate the long-term integrity and performance of the sterile barrier system (SBS) and packaging. Manufacturers must validate the product’s shelf life through real-time and/or accelerated aging studies to ensure continued sterility and package integrity over time. In accordance with EU MDR Annex II, the technical documentation must include design specifications, packaging validation data, aging study results, and evidence that the SBS maintains sterility throughout the declared shelf life. Annex III further requires ongoing post-market surveillance to monitor packaging performance in real-world use. Both aging methods must be properly validated, with all results documented in the device’s technical file to ensure EU regulatory compliance and protect patient safety. ToxyPals will prepare comprehensive Verification and Validation (V&V) plans and reports for stability studies in alignment with Notified Body requirements.

Ethylene Oxide (EtO) Sterilization Validation

Ethylene Oxide (EtO) sterilization validation for medical devices, as required by regulatory standards, follows a systematic approach to ensure consistent and effective sterilization. The process begins with Installation Qualification (IQ) to confirm proper installation of the equipment, followed by Operational Qualification (OQ) to verify that the sterilizer functions within specified parameters. Performance Qualification (PQ) involves microbiological validation using biological indicators (BIs) and bioburden data to demonstrate consistent achievement of the required Sterility Assurance Level (SAL) of 10⁻⁶. The validation plan outlines critical cycle parameters—such as temperature, humidity, gas concentration, and exposure time—tailored to the device's intended use and load configuration. Our team will develop a comprehensive Verification and Validation (V&V) plan and report for EtO sterilization to ensure full compliance with international standards and uphold patient safety.

Microbiological Testing Validation for Medical Devices

Our team will support manufacturers in preparing and reviewing plans and reports for sterility, bioburden, and endotoxin testing, ensuring the product meets release criteria and complies with regulatory requirements.

Transport Validation Studies

Our team will develop a comprehensive Verification and Validation (V&V) plan and report for transportation testing to ensure the durability and integrity of the medical device and its packaging throughout the distribution process.

Pre-Clinical or Biocompatibility testing

According to EU MDR, preclinical testing is mandatory before initiating a clinical trial if you intend to market your medical device in the European region. However, testing requirements can vary between Notified Bodies, and some regions may allow exemptions from preclinical testing if justified in accordance with their specific regulatory guidelines. Our team has hands-on experience in conducting in vivo toxicology studies, in vitro studies, and alternative in vitro models for medical devices. We also provide scientific justifications for study exemptions based on regional regulations. ToxyPals supports clients by optimizing preclinical protocols, overseeing toxicity studies, monitoring project progress, evaluating data, and reviewing reports to ensure quality and regulatory compliance.

Audit Checklists and Internal Audit Preparation

Our team develops customized audit checklists aligned with MDSAP, ISO 13485:2016, and EU MDR requirements, and conducts mock audit programs to help manufacturers prepare for USFDA inspections. Additionally, we perform supplier audits covering key Quality Management System (QMS) elements such as document control, CAPA, and risk management, along with regulatory traceability (including GSPR and technical documentation) and device-specific requirements such as biocompatibility, sterilization, and labeling.

Medical Devices

Invitro alternatives

Toxicity testing on animals is banned under EU regulations. In vitro studies using cell lines and alternative methods, such as the reconstructed human epidermis model, are the most suitable approaches for toxicity testing. Our team has expertise in handling in vitro and alternative testing models, and we support clients in selecting the appropriate model, preparing testing protocols, and compiling and reviewing reports to ensure product safety and facilitate regulatory approval.

Safety assessments reports

A toxicological safety assessment report is mandatory under both EU Cosmetic Product Regulation and US FDA guidelines. ToxyPals provides toxicological risk assessment services for cosmetic ingredients to determine whether a substance is permitted or classified as a restricted ingredient. Our evaluation includes hazard assessment, dose estimation, and exposure assessment, along with a thorough review of existing pre-clinical data. Based on these analyses, we prepare a comprehensive safety assessment report in compliance with regulatory standards.

Cosmetics

PDE/ OEL Determination

Our team has expertise in establishing Permitted Daily Exposure (PDE) and Occupational Exposure Limits (OEL) for chemicals and drug substances in accordance with regulatory requirements.

Toxicological Risk assessment

TRA is a mandatory requirement for pharmaceutical packaging systems to ensure that leachables remain within safe limits and cleaning agents are present at acceptable levels. Our ToxyPals team will review the chemical characterization report and assess the margin of safety for leachable to confirm compliance with regulatory standards.

Pharmaceuticals