Business Details
Your Trusted Partner for Technical Consulting Services
TNTC is a leading provider of technical consulting services to the pharmaceutical, biotechnology, medical device, and combination product industries. Our professionals bring decades of experience in project management, commissioning, qualification, engineering, quality assurance, and regulatory affairs, delivering solutions that align with evolving international regulatory expectations. We specialize in technical project management, regulatory program delivery, facility/equipment/utility qualification, automated system validation, and process/product design control and validation.Our team prioritizes client needs, employing industry best practices through active participation in organizations like ISPE, PDA, and PMP to ensure practical, compliant solutions. With a focus on science-based and risk-based approaches, we help clients achieve compliance-sensitive project goals efficiently while maintaining the highest standards of quality and patient safety.
Services
Technical Project Management
Regulatory Program Delivery
Facility Qualification
Automated System Validation
Process Validation
Highlights and features
- We have over 25 years of experience in life sciences technical consulting.
- Our team provides full-spectrum project management and regulatory compliance solutions.
- We implement science-based and risk-based approaches aligned with FDA/EU regulations.
- Our consultants maintain active involvement in ISPE, PDA, and PMP communities.
- We deliver cost-effective validation solutions using ASTM E2500-07 and GAMP5 frameworks.
Services
Technical Project Management
Our technical project management services combine industry expertise with proven methodologies to deliver life sciences projects on time and within budget. We employ earned value measurement and real-time assessment tools while maintaining compliance with regulatory requirements across pharmaceutical, biopharma, and medical device sectors. Our team specializes in managing IT/IS, operations, and quality-focused initiatives.
Regulatory Program Delivery
We provide comprehensive regulatory program delivery services to help clients achieve global marketing authorizations. Our consultants develop tailored regulatory strategies while ensuring compliance with FDA and EU requirements for medicinal products, medical devices, and food supplements. We focus on preventing regulatory obstacles through proactive planning and expert execution.
Facility/Equipment/Utility Qualification
Our facility and equipment qualification services follow ASTM E2500-07 and ISPE guidelines to create quality engineering-centric management systems. We implement cost-effective qualification approaches that shift responsibilities to engineering functions while maintaining patient safety standards. Our methodology maximizes efficiency without compromising compliance requirements.
Automated System Validation
We execute automated system validation projects using practical GAMP5 approaches. Our experienced engineers ensure software and system validation from implementation through go-live and beyond. We focus on delivering compliant validation documentation while maintaining system functionality and operational efficiency for life sciences applications.
Process/Product Design Control and Validation
Our process validation services apply risk-based methodologies to product qualification for medical devices and combination products. We follow FDA guidelines (21 CFR Parts 210/211), ICH Q7A, and 21 CFR Part 820 while creating compliant design history files. Our approach ensures market-ready products through science-based validation processes aligned with current regulatory frameworks.
Questions
What industries does TNTC serve?
We specialize in pharmaceutical, biotechnology, medical device, and combination product industries.
What services do you offer?
We provide technical project management, regulatory program delivery, qualification, validation, and compliance consulting services.
How many years of experience do your consultants have?
Our senior consultants have over 25 years of combined experience in life sciences technical consulting.
Do you follow international regulatory standards?
Yes, we maintain compliance with FDA, EU regulations, and industry guidelines like ISPE, PDA, and GAMP5.
