Services

Toxicology Risk Assessment

Our expert consultancy service offers meticulous evaluation of toxicological risks associated with agrochemicals, drugs, cosmetics, and medical devices. We ensure alignment with relevant standards and regulations to guarantee safety and compliance.

Laboratory Establishment and Compliance

Let us guide you through the process of setting up state-of-the-art laboratories that adhere to GLP and ISO 17025 standards. Our focus extends to in vitro and genetic toxicology labs, ensuring efficiency and regulatory compliance from the outset.

Interpretation of Toxicology Test Reports

Trust our team to decode and distill complex toxicology test reports into clear, actionable insights for regulatory submissions. We specialize in presenting findings comprehensively yet succinctly.

Sponsor-CRO Collaboration

Acting as a bridge between sponsors and Contract Research Organizations, we facilitate seamless coordination and oversight of pre-clinical toxicity studies, ensuring rigorous yet efficient execution.

PDE/OEL Document Preparation

Our meticulous approach to preparing Permitted Daily Exposure (PDE) and Occupational Exposure Limit (OEL) documents for drugs guarantees safety and compliance, earning the confidence of regulatory authorities

FDA Support

Navigating the complexities of FDA submissions can be daunting. Let us simplify the process and provide expert technical support for your 510k submissions, ensuring a smooth regulatory journey.

Biocompatibility Studies for Medical Devices

Our consultancy service specializes in crafting strategic approaches to biocompatibility studies in line with ISO 10993. From gap analysis to documentation support, we’ve got you covered every step of the way.

Scientific Writing Excellence:

Rely on our seasoned professionals to author SOPs, technical documents, and manuals with precision and clarity. We understand the importance of meticulous documentation in maintaining compliance.

Bespoke Test Protocol Design

No two projects are alike. That’s why we offer tailored solutions, designing custom test protocols and templates to meet your unique requirements and regulatory standards