Business Details
Your Trusted Partner for Technical Consulting Solutions
TNTC delivers technical consulting services and resources to the pharmaceutical, biotechnology, medical device, and combination product industries. Our professionals bring diverse expertise in project management, commissioning, qualification, engineering, quality assurance, and regulatory affairs, gained from decades of hands-on experience within operating companies. We prioritize delivering projects, commissioning, qualification, validation, and compliance consulting solutions that align with client business goals while adhering to strict timelines and budgets. Our approach combines intense research, intelligent inquiry, and unrelenting determination to meet client needs. By focusing on the right talent, methodologies, and dedication to excellence, we ensure successful project outcomes.Our team stays current with evolving regulatory frameworks and risk-based approaches, providing practical, compliant solutions. With over 25 years of experience, we specialize in technical project management, regulatory program delivery, facility/equipment/utility qualification, automated system validation, and process/product design control and validation. Our involvement in industry communities like ISPE, PDA, and PMP enhances our perspective on global regulatory expectations. We develop deliverables such as plans, specifications, qualifications, and risk assessments to support efficient compliance with best practices. Our commitment to client success is reflected in our process-oriented strategies that optimize team performance and communication through real-time assessment tools.
Services
Technical Project Management
Regulatory Program Delivery
Facility Qualification
Automated System Validation
Process Validation
Quality Assurance Consulting
Compliance Solutions
Risk-Based Approaches
Commissioning Projects
Validation Services
Highlights and features
- We have over 25 years of experience in pharmaceutical and biotech consulting.
- Our team stays current with evolving regulatory frameworks and best practices.
- We deliver projects on time and within budget using process-oriented strategies.
- Our consultants are actively involved in leading industry communities like ISPE.
- We provide risk-based, science-driven compliance solutions for global markets.
Services
Technical Project Management
TNTC provides technical project management services focused on delivering pharmaceutical and biotech initiatives on time and within budget. Our process-oriented strategies optimize team communication and performance through real-time assessment tools. With expertise in IT/IS, operations, and quality, we ensure alignment with client-specific objectives and regulatory requirements.
Regulatory Program Delivery
Our regulatory program delivery services support global approvals for medicinal products, medical devices, and food supplements. We design tailored regulatory strategies based on client product requirements and leverage deep expertise in FDA/EU regulations. Proactive problem-solving ensures compliance with evolving international standards and minimizes authorization delays.
Facility Qualification
TNTC executes facility, equipment, and utility qualification using ASTM E2500-07 and ISPE guidelines. Our engineering-centric approach streamlines compliance while maintaining cost efficiency and patient safety. We develop quality-focused deliverables that align with current good manufacturing practices and risk-based validation frameworks.
Automated System Validation
We provide automated system validation using the GAMP5 methodology, ensuring compliance for software and IT systems in regulated environments. Our experienced project managers and engineers support validation from planning through Go-Live, guaranteeing system reliability and adherence to industry standards.
Process Validation
TNTC offers process and product design control validation using risk-based approaches aligned with FDA, ICH Q8/Q9/Q10, and 21 CFR guidelines. Our methodologies ensure robust design history files and device master records, enabling clients to release high-quality products to market with confidence in compliance and patient safety.
Questions
What industries does TNTC serve?
TNTC serves pharmaceutical, biotechnology, medical device, and combination product industries with technical consulting and compliance solutions.
What services does TNTC specialize in?
We specialize in technical project management, regulatory program delivery, facility/equipment/utility qualification, automated system validation, and process/product design control and validation.
How does TNTC ensure regulatory compliance?
We stay current with evolving international regulations and risk-based frameworks, leveraging expertise in FDA/EU guidelines and industry standards like ISPE and ASTM E2500-07.
What experience does TNTC have?
Our team has over 25 years of experience executing commissioning, qualification, and validation projects for leading companies in regulated industries.
