Specialized Consulting Services

Provide protocol and process to certify internal company investigators and reviewers/approvers.

Provide specific SMEs to aid in litigation activities, depositions, opinion papers, and testimony.

FDA-recognized 3rd party Data Integrity expert for all remediation activities, including Application Integrity Policy (AIP).

TCG provides interim roles for employee extended leaves or succession planning. The roles are typically for senior leadership and range from 3 months to a year. 

Provide onsite client representation for sensitive operations or a quality oversight presence for CMOs and CDMOs on behalf of clients, including virtual companies.

Real-time project management and tracking for Managing Remediation projects as well as Internal projects, including facility modifications and quality system enhancements.

FDA-recognized 3rd party GMP expert for remediation activities.

Chemical toxicological evaluation and risk assessments.

Third-party review of batch records and products prior to release.

Specialized review during mergers and acquisitions of target companies to help buyers evaluate potential regulatory and compliance risks prior to acquisition.

Facilities, Equipment. Utilities, Support, URS, FRS, DS, DQ, IQ, OQ, PQ, CS, TM, and FAT/SAT.  Utilizing GAMP Methodologies.

EMPQ, Aseptic Process Simulations (Media Fills), Contamination Control Strategy, Operator Cleanroom behavior and personnel, material and waste flows.

Process Validation, Cleaning Validation, Computer System Validation (CSV), and Analytical Method Validation.

Develop procedures, policies, protocols, reports, work instructions, and forms, among other offerings.

QP audits and specific services for QP release.

Trouble shooting of processes and methods.

Serve as an FDA contact for international clients.