CMC and Manufacturing Consulting

Maximize your development efficiencies, identify and reduce potential risks, and implement your process development and manufacturing solutions to enable clinical studies no matter what phase your program is in.

Discover the Right Balance Between Cost, Safety, and Patient Access

Developing a new drug in a compliant way through every phase of the regulatory process is a noble and daunting endeavor.

It carries a considerable amount of risk including delayed timelines, loss of millions of dollars, or, worst of all, a potentially life-saving treatment for many people may not be realized.

It is essential that your work is not hindered by inefficient cost allocations, delayed timelines, or insufficient clinical trial material.

Accelerate Your Path to Approval

Identify & Mitigate CMC Risks

When developing a product, it is critical to manage both product and patient risks.

Unfortunately, during drug development, many companies overlook CMC risks resulting in delayed timelines, increased costs and rework.

Phase appropriate development and manufacturing is critical to your success.

TKD Solutions Services

Accelerate Your Path to Approval

Process Development

Process Development

  • Quality by Design (QbD)
  • Cell Line Development
  • Development Reports
  • Design of Experiments (DOE)
  • Technology Implementation
  • Transfer and Scale-up
  • Comparability
  • Troubleshooting
  • Technology and Facility Evaluations

Manufacturing

Manufacturing

  • On-Site Manufacturing Support
  • Batch Records
  • SOPs
  • Site Selection
  • Statistical Process Controls
  • Supply Chain

Process
Validation

Process
Validation

  • Critical Process Parameter Evaluation
  • Validation Protocols and Reports
  • Support Validation (Resin Re-Use, Membrane Re-Use, Hold Times, Loading Studies, etc.)

Analytical
Services

Analytical
Services

  • Cell Line Development
  • Validation Protocols and Reports
  • Method Development and Qualification
  • Hands-On Lab Support
  • Expert Review
  • SOPs
  • Analytical Method Transfer
  • Third Party Contract Laboratory Support
  • Product Characterization

Project Management

Project Management

  • Project Plans and Schedules
  • Team Organization
  • Meeting Management
  • Action Item Tracking
  • Budget Tracking
  • Project Status Reporting
  • Risk Management

Quality
Assurance

Quality
Assurance

  • Audits
  • Mock PAI/PLI Audits
  • Global Pre-Approval Inspection Readiness and Remediation
  • Programs
  • Quality Systems

CMC Regulatory Affairs

CMC Regulatory Affairs

  • Briefing Packages
  • Agency Responses
  • IND/IMPD, BLA/MAA, 510K, PMA, CE Mark, PAS or ROW Filings

Supply Chain Management

Supply Chain Management

  • Development & Execution of Clinical Supply Chain
  • Forecast DP demand, Expiry tracking & Inventory
  • Ancillary Equipment requirements
  • Development of distribution plan
  • Cold Chain, Chain of Custody, Ancillary equipment
  • Temperature Excursions
  • Establish appropriate geographic storage locations for R&D, DS, and DP materials to support CMC activities

Cross-Departmental Support

Cross-Departmental Support

  • Audits
  • Due Diligence
  • Integrated Strategic planning
  • Regulatory Interactions
  • Vendor Selection
  • Vendor oversight

An End-to-End Extension
of Your Team

TKD Solutions provides much more than consulting. We can become a full extension of your team in every phase. Our team runs deep and has subject matter experts ready to help wherever you are in your path to approval journey. TKD team members are chosen for their technical expertise and ability to work well with others. We can even act as your representative to your vendors, CROs, and CDMOs.

Strategy + Execution

We don’t just tell you what needs to be done. We roll our sleeves up and show you how to do it.

Identify and help mitigate risks from pre-clinical through commercial.

Connect you with and manage the CDMOs, vendors, and CMC experts needed to carry out your CMC activities.

Identify and develop your CMC strategy through innovative solutions and state of the art technologies.

Author and provide all technical and regulatory documentation.

We Save Our Clients Millions

Because we bring decades of experience to this space, we know how much things actually cost, and know what needs to be done for each phase of development.

Organizations that aren’t sure what to look for often end up wasting millions on unnecessary costs. We’ve built our reputation on the combination of our expertise and ability to provide an unmatched return on investment for our clients.

Getting Started with TKD Solutions is Easy

Contact Us

Call, email, or send us a message with your information through the contact form on this website.

Discovery Consultation

We’ll schedule a time to discuss what you need and what your timeline looks like. If we’re a good fit we’ll get started on a contract, CDA, and SOW.

Join Your Team

After all the t’s are crossed, and i’s are dotted, we get to work on solving your problem and accelerating your path to approval.

Your Hands On CMC Consulting Partner

TKD Solutions, LLC provides CMC and manufacturing consulting services with strategic and hands-on experience to aid clients in bringing products to market efficiently and with quality in mind.

$ Saved for Clients
Team Members
Combined Years of Experience

Ready to Find the solution to get your product to the people who need it most?

Focus on what you do best and we’ll do the rest.