Services
Auditing & Assessments
Regulatory Agency Response & Remediation
Auditing & Assessments
The TCG team, which consists of former regulatory inspectors and industry experts, has the capabilities and expertise to perform a wide array of audits and assessments. Examples include GMP, GCP, GLP, supplier audits, gap assessments, Mock Inspections, PAI Preparation/Readiness, Due Diligence, Data Integrity, and other specific Quality System topics.
Inspection Readiness
Regulatory Agency Response & Remediation
Auditing & Assessments
Inspection Readiness activities through TCG proves extremely valuable for companies, from helping them work through complex topics, preparing SMEs, or pressure testing the company’s inspection management process. These activities are particularly valuable for companies hosting their first regulatory inspection.
Regulatory Agency Response & Remediation
Regulatory Agency Response & Remediation
Regulatory Agency Response & Remediation
TCG has a proven track record of helping companies successfully navigate through regulatory enforcement actions with successful outcomes. Additionally, we can rapidly mobilize a team of remediation experts. Our approach is a holistic response to enforcement actions, ensuring that your response, remediation plan, and CAPAs are comprehensive.
Specialized Services
Specialized Services
Regulatory Agency Response & Remediation
Our specialized services include everything from QP services to Toxicological assessments, expert witnesses, interim roles, and many other services across the pharmaceutical, biologics, and medical device industries.
Regulatory Support
Specialized Services
Education & Training
We employ former agency regulatory reviewers and industry regulatory affairs experts who have reviewed and submitted regulatory submissions, helped develop submission-ready briefing packages, and facilitated FDA/Agency meetings.
Education & Training
Specialized Services
Education & Training
TCG training is driven by client needs. Often, training is needed on new guidance documents or to increase understanding of specific topics (i.e., Data Integrity) among their personnel. We will develop a customized solution to fit your needs.
Industries
Pharmaceuticals
From OTC to prescription drug products, TCG provides consulting services to assist with all phases of development, from preclinical to post-commercialization. We have expertise in all dosage forms, from solid oral dosage to aseptically processed parenteral products, as well as combination products.
Biologics
Our team has extensive experience supporting Biologics firms with different processes, including cell culture, fermentation, purification, harvest, clarification, and capture. We are also experts in a wide variety of Biologic products, including Vaccines, Blood and blood components, Allergenics, Somatic Cells, Cell and Gene therapy, tissues, and Recombinant therapeutic proteins.
Medical Devices
The TCG team has experience with Class I, II, and III device manufacturers, including those manufacturing combination products. We also have extensive experience assisting clients in achieving compliance when addressing FDA enforcement actions, as well as providing regulatory submission support for 510(k)s and Premarket Approval (PMA).