While most biopharmaceutical products are conceived in R&D, by the end of a product’s path to approval, the R&D department generally comprises less than 5% of the overall personnel contributing to the campaign.

As your candidate advances on its journey to approval, contributions are required from upstream and downstream manufacturing, fill/finish, quality assurance, technical operations, supply chain, logistics and finance departments among many other specialists who can address the unique challenges of each product’s path to regulatory approval. In addition to internal departments, companies will be interfacing with regulatory authorities, CDMOs, and consultants to meet the stringent requirements to bring a new drug to market.

At TKD Solutions, we are experienced professionals with a diverse set of pharmaceutical backgrounds who have contributed to many different departments at different stages of product lifecycles. We can strategize and interface with all the departments required to take your product to regulatory approval whether they are internal groups our outsourced partners.

We recognize that programs for cell and gene therapies and biologics have many specialized departments for genetic engineering, cell line development, and purification, to name a few; and we understand that all the unique departments must work in concert to reach regulatory approval.

We have experience bridging R&D with MS&T to develop product specifications and choose appropriate testing and scale-up conditions. We can also ensure alignment between MS&T, CDMOs and supply chain as clinical demand ramps up. We will regularly engage quality assurance to ensure a program is compliant at every stage of its lifecycle, and we have the experience to support audits and regulatory interactions.

With the many personnel of various backgrounds responsible for a product’s success, it is imperative to have cross-departmental support that is well-versed in all areas of development from R&D to quality and everything in between, and at TKD we provide you a team of professionals who have experience interfacing with all the departments required to reach regulatory approval.

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

Learn how we can bridge the gaps for a more efficient operation.

Nonclinical / Early Phase Development Process Development Regulatory Affairs Cross-Departmental Support Analytical Development Project Management Manufacturing Science & Technology Nonclinical / Early Phase Development Process Development Manufacturing Science & Technology Analytical Development Project Management Regulatory Affairs Cross-Departmental Support