Compliance and Validation Consulting

We provide critical GxP-based consulting services throughout the product lifecycle to help our clients successfully execute projects to bring products to market and maintain quality and compliance with applicable regulations and industry standards.

Our team of qualified experts applies proven and proprietary project management methodologies to help our clients successfully develop and launch products to market. We offer an expansive suite of services to ensure quality, compliance, efficiency, and safety throughout the full lifecycle of a product. Working as an extension of your team, we support you with the highest quality of services providing best practices and proven insights on program and process management aligned with our mission to improve the health and safety of patients.

A proactive and prescriptive approach to maintaining and elevating the stature of your quality systems, ensuring the highest compliance standards are met.

    • Quality Management Systems (QMS)
    •  Remediation
    • Quality Assurance (QA)
    • Qualified Person (QP) and Responsible Person (RP)
    • Pre-Approval Inspection and GxP Audits

Our teams use proven and proprietary methodologies to mitigate project costs, accelerate timelines, and improve commercial probability.

    • Technology Transfer
    • Process Optimization
    • Program and Project Management
    • Process and Product Development Management
    • Third-Party Selection Services

We partner with your internal teams to develop continuously reliable and compliant production services, to meet the highest GMP standards. 

  • Process Validation
  •  Cleaning and Sterilization Validation
  • Good Manufacturing Practices (GMP) Product Lifecycle Methods
  •  Computer System Validation
  • Equipment and Facility Engineering

We position your projects for success with years of real-world experience managing projects of various scale, complexity, and importance.

  •  Bioprocess Engineering
  •  Process Architecture and Facility Design
  • Equipment and Facility Engineering
  • Process Automation

We provide best-in-class global clinical services to ensure safe and effective clinical conduct and support for your patients’ health and safety.

    • Medical Monitoring
    • Data Safety Monitoring Board
    • Safety Management Plan (SMP) Development

TK-Chain’s CET (Compliance expert team)

Our team of compliance and quality specialists bring a breadth and depth of experience applying proven and proprietary project management methodologies to help our clients successfully bring products to market. Whether you need short- or long-term staffing/consulting resources, GxP consulting services, or rapid remediation assistance to get a project back on track, we provide the tailored solution to meet your unique needs.

Regulatory Affairs Consulting

We help clients achieve positive regulatory outcomes using a scientific approach as the driver of success. As the world’s leading provider of regulatory consulting services, we support our clients from pre- through post-approval for both the U.S. Food and Drug Administration (FDA), Health Canada and the European Medicines Agency (EMA).

Our aim is to make your business succeed. TK-Chain’s experienced team commands a breadth and depth of knowledge pertaining to the FDA, Health Canada and EMA regulatory frameworks and can work with you to accomplish your regulatory and business objectives. We develop regulatory strategies for your product, providing a clear path forward through all the critical milestones to achieve a successful outcome. We can also help with your post-authorization regulatory needs, including the launch of your product, line extensions (LE) and variations, and maintaining your products’ optimal regulatory status throughout its lifecycle.

• Regulatory strategy/Gap Analysis
• Nonclinical Drug Development
• Pre-Approval Audits
• Medical Devices meetings
• Medical Device Submissions
• Regulatory Deliverables
• Medical/Technical Writing
• Scientific Advice and Pre- submission Meetings
• Submissions and Procedural Management
• Dossier Compilation and Publishing
• Submission Management
• Product Launch
• Product Information (PI)
• Post – authorization Commitments

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