Helping biotech, pharma, and their third-party partners and service providers ensure quality throughout the product development process and post-approval lifecycle management.
Regulatory Compliance Lifecycle
Processes we can handle:
Create Quality Management System (QMS)
Provide in-person and virtual training
Adjudicate preclinical and clinical data
Audit sponsors, CMC, vialing, labeling, clinical and bioanalytical labs, companion diagnostic (CDx) partners, and clinical sites
GxP pre-approval and surveillance inspections
Liaise with CROs and sponsors for resolution of study conduct-related issues
Setup and coordinate call centers for post-marketing activities
Handle product complaints and recalls
With our vast experience in regulations in North America, Latin America, Europe, Japan, and China, we support the harmonization of global processes
Documents we can audit, review, or draft:
SOPs, policies, and training materials
Regulatory packages for clinical sites
Study protocols
Investigational New Drug (IND) application
Database lists and electronic Case Report Form (eCRF)
Clinical Study Report (CSR)
Investigator's Brochure (IB)
Informed Consent Forms (ICF)
Trial Master Files (TMF)
New Drug Applications (NDA)
Responses to regulatory agencies findings with CAPAs
Responses to FDA Form 483 and warning letters
CDx significant risk determination (SRD), investigational device exempt (IDE), and pre-market application (PMA)