Specialized Consulting Services
TCG is a full-service consulting firm offering a wide range of specialized services, from Qualified Person and facility design reviews to toxicology services and more. Additional services are also provided; please inquire below.
Specialized Services
Investigator Certification
Investigator Certification
Investigator Certification
Provide protocol and process to certify internal company investigators and reviewers/approvers.
Expert Witnesses
Investigator Certification
Investigator Certification
Provide specific SMEs to aid in litigation activities, depositions, opinion papers, and testimony.
Data Integrity
Investigator Certification
Data Integrity
FDA-recognized 3rd party Data Integrity expert for all remediation activities, including Application Integrity Policy (AIP).
Interim Roles
Person-in-Plant (PIP)
Data Integrity
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.
Person-in-Plant (PIP)
Person-in-Plant (PIP)
Person-in-Plant (PIP)
Provide onsite client representation for sensitive operations or a quality oversight presence for CMOs and CDMOs on behalf of clients, including virtual companies.
Project Management
Person-in-Plant (PIP)
Person-in-Plant (PIP)
Real-time project management and tracking for Managing Remediation projects as well as Internal projects, including facility modifications and quality system enhancements.
GMP
Third-Party Certifications
Toxicology Services
FDA-recognized 3rd party GMP expert for remediation activities.
Toxicology Services
Third-Party Certifications
Toxicology Services
Chemical toxicological evaluation and risk assessments.
Third-Party Certifications
Third-Party Certifications
Third-Party Certifications
Third-party review of batch records and products prior to release.
Due Diligence
Commissioning and Qualification
Third-Party Certifications
Specialized review during mergers and acquisitions of target companies to help buyers evaluate potential regulatory and compliance risks prior to acquisition.
Commissioning and Qualification
Commissioning and Qualification
Commissioning and Qualification
Facilities, Equipment. Utilities, Support, URS, FRS, DS, DQ, IQ, OQ, PQ, CS, TM, and FAT/SAT. Utilizing GAMP Methodologies.
Aseptic Processing Topics
Commissioning and Qualification
Commissioning and Qualification
EMPQ, Aseptic Process Simulations (Media Fills), Contamination Control Strategy, Operator Cleanroom behavior and personnel, material and waste flows.
Validation
Technical Writing
Technical Writing
Process Validation, Cleaning Validation, Computer System Validation (CSV), and Analytical Method Validation.
Technical Writing
Technical Writing
Technical Writing
Develop procedures, policies, protocols, reports, work instructions, and forms, among other offerings.
Qualified Person (QP) Services
Qualified Person (QP) Services
Qualified Person (QP) Services
QP audits and specific services for QP release.
Technical Consulting
Qualified Person (QP) Services
Qualified Person (QP) Services
Trouble shooting of processes and methods.
Additional services are also provided; please inquire below.
Contact Us
Have Questions?
Thank you for your interest in Toscano Consulting Group (TCG). Do not hesitate contacting us for any of your consulting needs.
Toscano Consulting Group
Phone: (786) 201-3663 Email: operations@thetcg.org
Hours
Mon | 09:00 am – 05:00 pm | |
Tue | 09:00 am – 05:00 pm | |
Wed | 09:00 am – 05:00 pm | |
Thu | 09:00 am – 05:00 pm | |
Fri | 09:00 am – 05:00 pm | |
Sat | Closed | |
Sun | Closed |