TKD Solutions Services

CMC and Manufacturing Consulting Partners

TKD Solutions helps biotech organizations in Pre-IND through commercialization in two different ways.

  • Our team can act as consultants and set you up for success.
  • Or we can roll up our sleeves, become an extension of your team, and provide hands-on execution during any phase of drug development.

TKD’s end to end services come with decades of
experience and expertise in a wide range of
products.

Antibodies

Biosimilars

Cell & Gene
Therapy

Combination Products

Medical Devices Products

Oligonucleotides

Recombinant
Proteins

Vaccines

Process Development

Expedite your path to the clinic and commercial launch. TKD streamlines and prioritizes development based on program risks, and ensures a right first time approach. Save on the cost of development and stay compliant throughout the lifecycle of your program.

  • Quality by Design (QbD) approach
  • Identification & Implementation of Development Strategy
  • Cell Line Development
  • Development Reports
  • Design of Experiments (DOE)
  • Technology Implementation
  • Tech Transfer and Scale-up
  • Comparability
  • Troubleshooting
  • Technology and Facility Evaluations
  • Process Characterization

Manufacturing

TKD helps streamline both internal or contracted manufacturing. We can identify the right manufacturer, provide CDMO management on your behalf, and ensure that the right oversight is in place to enable program success.

  • On-Site Manufacturing Support
  • Batch Record authoring & review
  • SOP authoring
  • Site Selection
  • Make vs. Buy
  • Statistical Process Controls
  • Supply Chain

Process Validation

Develop a comprehensive process validation strategy early in development to ensure an efficient approval and lifecycle management process. TKD ensures you have phase appropriate process validation activities in motion at every phase of development..

  • Process Risk Assessments
  • Critical Process Parameter Evaluation
  • Material Risk Assessments
  • Validation Protocols and Reports
  • Setting Acceptance Criteria
  • Support Validation Executions

Analytical Services

TKD helps set your strategy early. Ensure your analytical methods are fit for purpose and fit for use based on your program strategy and Critical Quality Attributes. We ensure you have phase appropriate methods in place to prevent late phase rework and/or regulatory challenges.

  • Critical Quality Attribute Risk Assessment
  • Method Development and Qualification
  • Validation Protocols and Reports
  • Hands-On Lab Support
  • Expert Review
  • SOPs
  • Specification Development
  • Analytical Method Transfer
  • Third Party Contract Laboratory Support
  • Product Characterization

Project Management

TKD works with your current project management platform and helps develop a CMC project management strategy. From establishing a project plan through day-to-day meeting attendance and agendas to keeping teams organized, we can provide the support you need to create an effective and efficient work environment for your team.

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

Quality Assurance

Quality assurance through every phase of development is critical to getting your drug approved. If you don’t already have a QA system in established or need help refining an existing one TKD can help. We provide oversight for audits, perform mock inspections, and keep your program compliant.

  • Audits
  • Mock PAI/PLI Audits
  • Global Pre-Approval Inspection Readiness and Remediation Programs
  • Quality Systems
  • Batch Record Review
  • SOP Authoring

Regulatory Submissions

TKD can help identify and implement appropriate regulatory strategy for your program through all phases of development and lifecycle management. In addition, TKD will help you by authoring Module 3 components and generating supporting documentation as needed to ensure acceptance of your dossier.

  • Regulatory strategy and risk identification
  • Briefing Packages
  • Agency Responses
  • IND/IMPD, BLA/MAA, 510K, PMA, CE Mark, PAS or ROW Filings
  • Regulatory interactions

Supply Chain Management

TKD can support your Supply Chain needs from a CMC perspective and clinical perspective. We can help with forecasting and keeping track of expiration, inventory, and cold chain custody. If you need help finding the right supply chain vendors we can identify the best solutions to ensure compliance wherever you are in the world.

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

Cross Departmental Support

TKD provides cross departmental support of a variety of activities to enable your program success.

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

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.