We support every stage of compound progression, from target identification/toxicological risk assessment, through lead-generation/optimisation, to life-cycle maintenance. Our extensive experience will help you design, run and interpret the studies necessary for your IND/IMPD submission and we will guide you through the associated FDA/EMA/PMDA interactive process.
Slide Reading and Interpretation:
At PathCelerate, we excel in the performance of high-standard primary slide reading, in addition to the provision of a comprehensive peer-review service.
We hold both FRCPath (British) and ACVP (American) board-certification, ensuring full international compliance, acceptance and recognition.
With vast experience in pharmaceutical discovery and development, we proudly offer expertise and assistance in the following:
•Short and long-term regulatory protocols.
•Oral, inhalation and intravenous screening.
•Small molecule, biologic and oligonucleotide evaluation.
•Pharmacodynamic biomarker analysis.
•Disease model assessment.
•Ecotoxicological and aquatic toxicity testing.
Providing you with confidence in the full range of investigative and regulatory efficacy and safety studies, we can assist in the design, implementation and interpretation of each study, fortifying your research and maximizing your drug-development program.
From Contract Research assistance, where an “extra pair of hands” may be required, to a full and comprehensive consultant preclinical service, in garnering our consultant pathologist expertise, we can work together to fulfil your business objectives and bolster your pipeline.
Did you know?
Second opinions, available via our external peer review service, are often requested by Clients in order to fully understand and appreciate the implications of a particular preclinical pathology finding. We work collaboratively with Contract Research Organizations in maximizing the validity and usability of the data generated, tailoring the output and making it fully fit-for-purpose as per a Client’s individual needs.