TCG is a full-service consulting firm providing clients with a wide range of services supporting companies from early stage development to post commercialization activities.
Auditing and Assessments: GMP, GCP, GLP, BIMO, OTC, supplier audits, gap assessments, Mock Inspections, PAI Preparation/Readiness, Due Diligence, Data Integrity, and other specific Quality System topics
Enforcement Action Support: 483, Warning Letter, Import Detention, Untitled Letter, Consent Decree (Permanent Injunction), Application Integrity Policy (AIP) Response and Remediation
Regulatory: Regulatory Strategy and Submissions; filing support for Drugs, Biologics and Medical Devices - ANDA, NDA, 505(b)2, BLA, IND, Clinical Development, 510(k), and PMA
Training: Inspection Readiness Training, Auditor Training, Data Integrity Training, Aseptic Processing, and more
Due Diligence: Specialized auditing and review services in support of mergers and acquisitions
Interim Roles: Specialized auditing and review services in support of mergers and acquisitions
Person in Plant (PIP): Provide oversight for sensitive operations or a quality oversight presence for CMOs on behalf of clients, including virtual companies
Expert Witness: Specific SMEs in support of litigation activities
Commissioning and Qualification: Facilities, Equipment. Utilities, Support,
URS, DS, IQ, OQ, PQ, CS, DS, TM, and FAT/SAT
Validation: Process Validation, Cleaning Validation, Computer System Validation (CSV), and Analytical Method Validation