Katalyst Healthcares & Life Sciences
Katalyst HealthCares & Life Sciences is a global Contract Research Organization providing services in Clinical Research, Manufacturing & Quality, Regulatory Affairs, and more. They serve industries including Pharmaceutical, Bio-Pharmaceutical, Medical Device, Cosmeceuticals & Cosmetics, Food & Beverage, and Clinical Research. Their mission is to accelerate drug development with quality and safety, contributing to a safer, better world. Their vision is to increase human life expectancy through science innovations, simplifying business challenges and optimizing global health.
Industries
Nr. of Employees
medium (51-250)
Katalyst Healthcares & Life Sciences
285 Durham Ave, Suite 12, South Plainfield, NJ 07080
Products
Clinical Trial Operations (CTO) Services
Services include comprehensive clinical trial management from start-up through reporting for pharmaceutical, biotechnology, and medical device companies.
Clinical Data Management
Involves processes and technology for accurate and efficient management of clinical trial data from Phase I-IV across various therapeutic areas.
Data Analysis (Statistical)
Provides biostatistical services including sample size calculations, statistical analysis plans, and analyses for clinical trials.
Medical/Scientific Writing Services
Covers a range of documents including clinical study protocols, regulatory submissions, and pharmacovigilance documents.
Pharmacovigilance and Drug Safety Services
Monitors adverse events and serious adverse events in clinical trials to ensure volunteer safety, using systems like Oracle Argus.
Regulatory Affairs
Offers consulting services for product registration in global markets, including regulatory submissions in eCTD format.
Clinical Trial Operations (CTO) Services
Services include comprehensive clinical trial management from start-up through reporting for pharmaceutical, biotechnology, and medical device companies.
Clinical Data Management
Involves processes and technology for accurate and efficient management of clinical trial data from Phase I-IV across various therapeutic areas.
Data Analysis (Statistical)
Provides biostatistical services including sample size calculations, statistical analysis plans, and analyses for clinical trials.
Medical/Scientific Writing Services
Covers a range of documents including clinical study protocols, regulatory submissions, and pharmacovigilance documents.
Pharmacovigilance and Drug Safety Services
Monitors adverse events and serious adverse events in clinical trials to ensure volunteer safety, using systems like Oracle Argus.
Regulatory Affairs
Offers consulting services for product registration in global markets, including regulatory submissions in eCTD format.
Services
Operational support for clinical studies including trial management, monitoring, site selection, study start-up, feasibility, volunteer recruitment, supplies and project management across Phase I–IV.
Preparation of clinical and regulatory documents including protocols, CRFs, investigator brochures, CSRs, consent forms, IND/NDA/BLA submissions, and risk management plans.
Case processing, aggregate safety reporting, signal detection and assessment, risk management planning, and 24x7 medical call center support.
Regulatory strategy, dossier preparation, electronic submissions (eCTD), labeling support, and regulatory agency liaison for global markets.
Quality systems development, internal/external auditing, inspection readiness, and validation of facilities, equipment, processes and computer systems to cGxP standards.
Design and conduct of device feasibility, pilot, PMCF and post-market studies, regulatory submissions (510(k), PMA, De-novo), and EU MDR/IVDR consulting including vigilance and PMCF reporting.
Operational support for clinical studies including trial management, monitoring, site selection, study start-up, feasibility, volunteer recruitment, supplies and project management across Phase I–IV.
Preparation of clinical and regulatory documents including protocols, CRFs, investigator brochures, CSRs, consent forms, IND/NDA/BLA submissions, and risk management plans.
Case processing, aggregate safety reporting, signal detection and assessment, risk management planning, and 24x7 medical call center support.
Regulatory strategy, dossier preparation, electronic submissions (eCTD), labeling support, and regulatory agency liaison for global markets.
Quality systems development, internal/external auditing, inspection readiness, and validation of facilities, equipment, processes and computer systems to cGxP standards.
Design and conduct of device feasibility, pilot, PMCF and post-market studies, regulatory submissions (510(k), PMA, De-novo), and EU MDR/IVDR consulting including vigilance and PMCF reporting.
Expertise Areas
- Clinical trial management
- Clinical monitoring and site management
- Pharmacovigilance and drug safety
- Regulatory affairs and submissions
Key Technologies
- Electronic data capture (EDC) and clinical trial management systems (CTMS)
- Safety database systems for case management
- eCTD and electronic regulatory publishing systems
- Statistical analysis and clinical programming software (e.g., SAS)