Chemva authored an ISO 10993-18 and USP <1663>/<1664>-aligned E&L study design for a high-risk parenteral prefilled syringe, accepted by FDA without information requests.

Chemva built a unified ICH Q3D and USP <232> cumulative PDE model for a wearable autoinjector, accepted by FDA at pre-submission without additional elemental testing.

Chemva delivered a CPCA- and read-across-based NDSRI risk assessment ahead of FDA/EMA nitrosamine compliance deadlines, avoiding reformulation on a widely prescribed oral API.

Chemva converted a legacy AET/PDE toxicological framework into an ISO 10993-17:2023-aligned compound-specific TI derivation for a permanent orthopedic implant, resolving an FDA information request without repeating chemistry testing.

Chemva recommended a dual Toxicological Risk Assessment (TRA) strategy, using results from E&L testing

Chemva performed a tiered in-silico genotoxicity assessment using (Q)SAR tools and expert toxicological interpretation to classify the packaging-derived impurities per ICH M7 guidelines.

Chemva proposed and executed a paper-based Material Risk Assessment (MRA) specifically designed to address both genotoxic and non-genotoxic carcinogenicity pathways.

Chemva performed a comprehensive risk assessment focused on understanding whether the antioxidant reduction would materially impact the polymer’s performance, stability, or toxicological profile.

Chemva swiftly conducted a comprehensive Material Risk Assessment

Chemva led a detailed material-specific risk assessment, supported by both scientific literature and historical clinical use.

Chemva conducted a comprehensive Toxicological Risk Assessment (TRA) using a read-across strategy, allowing us to bridge data gaps with scientifically valid surrogate information.

Chemva designed and executed a custom reverse engineering plan targeting both bulk materials and surface coatings of the competitor’s connector and delivery components.

Chemva conducted a comprehensive material equivalency assessment to evaluate potential variations between batches sourced from the original and new manufacturing sites.

Chemva conducted a systematic, material-specific MRA, analyzing each component and processing additive and manufacturing steps to identify chemical structures or precursors associated with CoCs.

Leveraging our deep expertise in biocompatible coatings and polymer systems, Chemva led a coating reformulation and optimization program tailored to the device’s surface, application method, and clinical use.

Chemva led a material compatibility evaluation using HansenSolubility Parameters (HSP) to scientifically assess the interaction potentialbetween each candidate hub material, the bonding solvent, and the polyurethanetubing.

Chemva conducted a comprehensive review of the E&L protocol, evaluating analytical strategies, extraction conditions, and toxicological relevance.

Chemva’s semi-targeted E&L design eliminated potential FDA objections before they could be raised.

Chemva developed and implemented a risk-based supplier qualification framework

Developed a risk-based BEP to meet FDA and ISO 10993-1 standards, helping the client avoid delays and save $300K through targeted testing.

Chemva’s systematic approach not only resolved the cracking issue but also enhanced the product’s long-term reliability and manufacturability.

Chemva led a detailed material-specific risk assessment, supported by both scientific literature and historical clinical use.

Chemva led a contextual data evaluation to assess whether the positive result represented a real clinical risk.

Chemva’s strategic data interpretation helped the partner avoid unnecessary re-testing and product reformulation

Chemva implemented a multi-step vendor qualification strategy to identify a reliable source of medical-grade polymer materials.