Regulatory and toxicological consulting for medical devices and pharmaceuticals — supporting compliance, product safety, and market authorization at every stage.
The foundational ISO 10993-1 document defining your device's body-contact category and duration, and the biological endpoints — cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, and implantation effects — that must be evaluated.
Learn moreEvaluates health risks from chemicals that may leach from a device's materials, comparing exposure against toxicological thresholds like the Tolerable Intake or TTC — critical for prolonged or permanent-contact devices.
Learn moreIdentification and quantification of chemicals in or released from a device, through extractables (exaggerated conditions) and leachables (clinically relevant conditions) studies that feed directly into the risk assessment.
Learn moreThe culmination of the biological evaluation process — compiling all data, testing, literature, and risk assessments into the safety conclusion regulators review for FDA 510(k)/PMA or EU MDR technical files.
Learn moreA systematic review comparing your device's existing documentation, testing, and quality processes against current requirements (EU MDR, FDA 21 CFR, ISO standards), identifying deficiencies and a prioritized action plan — especially valuable when transitioning frameworks (e.g. MDD to MDR) or entering new markets.
Learn moreBiocompatibility evaluation of breathing gas pathways in ventilators, anesthesia machines, and similar devices — covering particulate emissions, VOCs, and condensate leachables across Parts 1–4.
Learn moreReviewing the intrinsic properties of an active ingredient, excipient, or impurity — toxicological data, structure-activity relationships, and literature — to flag potential carcinogenicity, mutagenicity, or reproductive toxicity.
Learn moreQuantifying how patients are exposed to a substance — dosage, frequency, duration, and route of administration — to establish real-world exposure levels for comparison against safety thresholds.
Learn morePreparing toxicology summaries and safety assessments for IND, NDA, ANDA, or Marketing Authorization Application filings in the format required by FDA, EMA, and other regulators.
Learn moreIdentifying, qualifying, and assessing impurities and degradation products — including genotoxic and elemental impurities — per ICH Q3A/B/C/D and M7 to set acceptable limits.
Learn moreOngoing monitoring and reporting of adverse drug reactions — case processing, signal detection, PSURs/PBRERs, and risk management plans — to meet post-market safety obligations.
Learn moreSystematic review of existing scientific and clinical literature relevant to the product.
Identifying and quantifying chemical constituents and extractables/leachables.
Evaluating health risk based on chemical and exposure data.
Assessing biocompatibility in line with ISO 10993.
Identifying missing data or documentation against current regulatory expectations.
Quantifying the nature, duration, and extent of patient exposure to a device or its constituents.
Preparing and reviewing the documentation regulatory submissions require.
| Standard / Guidance | What It Covers |
|---|---|
| ISO 10993 Series | Biological evaluation of medical devices within a risk management process. |
| ISO 14971 | Application of risk management to medical devices. |
| FDA Guidance | Requirements and expectations for U.S. regulatory submissions. |
| European MDR | Compliance with the EU Medical Device Regulation. |
| ICH M7 | Assessment and control of DNA-reactive (mutagenic) impurities to limit carcinogenic risk. |
| ICH Q3A/B/C/D | Acceptable limits for impurities, degradation products, and elemental impurities in drug substances and products. |
| Good Scientific Practices | Methodological rigor, transparency, and data integrity across all assessments. |
| Client-Specific Requirements | Internal protocols or additional requirements specified by the client. |
We review your product, intended use, and target markets to define the right scope of work.
Existing technical files, material data, and prior studies are reviewed for gaps and reusable data.
Our accredited toxicologists and scientists carry out the required evaluation — biological, chemical, or toxicological.
Findings are compiled into clear, regulator-ready reports and documentation.
Every report passes internal scientific review before delivery to ensure accuracy and defensibility.
We remain available to address regulator queries or follow-up requests after delivery.
A clear, scientifically rigorous report aligned to the relevant ISO, FDA, or MDR standard.
Regulator-ready documentation suitable for direct inclusion in your submission.
A defensible, evidence-based rationale behind every safety conclusion.
Direct access to the accredited experts behind the assessment for follow-up questions.
Our scientific and regulatory experts will help you scope the right assessment for your product.
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