Veracord staff assists clients with all types of validation, including Computer systems and software validation, Laboratory equipment, systems and methods, Process Validation, Equipment validation, Facility Commissioning; Qualification, and Validation, and Cleaning Validation.
Veracord a comprehensive range of auditing services to assist in preparing for Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Quality System Regulations (QSR) inspections by Regulatory Authorities, clients and corporate partners. We also offer Regulatory Inspection Preparation audits, Vendor Audits, and study-specific GCP audits of protocols, investigator sites, master files, pharmacovigilance, databases and reports for a wide variety of clinical studies.
Veracord facilitates and manages projects on stand-alone basis or brings PMO capabilities to support all your needs. Our team members are SMEs in the applications and technologies involved in the project, and work within the framework of each client's business processes according to their compliance needs.
Veracord Compliance Consulting assists Life Science companies with Executive Counseling on FDA Compliance Matters, Compliance Improvement Strategies, FDA Inspection Preparation and Training, FDA Registration and Product Listings, Corrective and Preventive Actions (CAPA), Complaints, Non-Conformances, Out-of-Specification (OOS) Incidents, and Change Controls.
Veracord staff assists you with developing clinical and drug development plans – always starting with the end in mind. We help by getting your products GMP-compliant and ready for the clinic; designing and coordinating GLP- compliant toxicology studies in support of human studies; coordinating meetings with International regulators; writing up all types of applications to regulators pre-IND, IND, NDA, etc., and designing and writing protocols, investigator brochures and marketing applications.
Medical Device Services
Veracord supports medical device companies with everything from regulatory strategies, risk management, submissions, compliance, review of internal standard operating procedures for quality control, inspections, validation, qualification (IQ, OQ, PQ), investigations, root-cause analyses, and CAPA planning.