Life Science Consulting

Ensure Quality and Regulatory Requirements are Met Throughout the Product Lifecycle


Regulatory organization demand that manufacturers maintain compliance throughout all stages of a product’s lifecycle, from concept to commercialization, including postmarket compliance. Maintaining compliance for your particular product at its present status in the lifecycle is a difficult challenge unique to each company, and one which requires continual attention and support.

TK Chain specializes in solving these difficult challenges. As an extension of your team, we care about not only the progression of your products, but furthermore the security and safety of your products and the patients who use them. Our highly trained experts seamlessly integrate with your organization to do more than normally identify potential risks. We provide recommendations to mitigate those dangers and risks, work side-by-side with you to implement improvement plans, and train your staff how to address those risks when our job is done.

TK Chain is your global, single source for professional insights pertaining to technical, quality compliance, and regulatory assistance throughout the product lifecycle, including:

AIQ, LEQ, & Methods Validation
Analytical Development
Bioprocess Engineering
Cleaning Validation
Clinical IMP Management
CMO Identification & Selection
Commissioning & Qualification
Compliance & Remediation
Compounding Pharmacy
Computer Systems Validation
CSV Auditing
Environmental Monitoring
Formulation Development
GCP Auditing
GMP Auditing
PAI Readiness
Process Architecture & Facility Design
Process Optimization
Process Validation
Procurement & Construction Supervision
Product Development Management
Program & Project Management
QP Product Release
Quality Assurance
Quality Management Systems
Scientific Writing
Sterilization Validation
Supplier Management
Technology Transfer
Upstream & Downstream Process Development

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