SPLY Project Consulting

Project Management

Partner with SPLY to strategize and execute your project. 


We provide consultancy based on technical expertise combined with a broad understanding of the business processes within the clinical area.


We can help you through CMC and supply related projects both in the planning and the execution phases, which will let you focus on your business and processes.


Get in touch to learn more about how this service can help you.

 

Example Projects

Case Description

IRT System Selection and Implementation

Solution: System requirement specification, tender management (RFI/RFP) and SOP adjustments. We worked on this project with a focus on selecting a system that could support the company's complex trial designs and could be streamlined with the operational process-steps. 
Duration: 5 months
Reporting to: VP CMC
Client: Biotech Company

QMS Framework

Solution: Created and implemented a Quality Management System to support cGMP and cGDP compliance at supply and logistics department. The system was aligned with company Quality Assurance guidelines for document control, CAPA, customer compliant, internal auditing, and management review.
Duration: 3 months
Reporting to: Head of Clinical trial Supply

Client: Biopharmaceutical Company

Training and Coaching Clinical Supply Managers

Solution: On-site role with responsibility for six clinical supply managers, and hire of permanent Department Head. 
Duration: 8 months
Reporting to: Senior Director CMC
Client: Biotech Company

 

Contact Us

Fruebjergvej 3, 2100 Copenhagen, Denmark

+4560198464

 

Wish to Join the Sply Consulting Group?

You will get the best of both worlds as a consultant in Sply. Part of an experienced group while keeping your flexibility as an independent business owner. 


Get in touch to learn more!    

We are looking forward to meeting with you!

Submit a few words and your CV

 

Sply

+4560198464

Fruebjergvej 3, 2100 Copenhagen, Denmark

© 2017 - 2020
Sply ApS: CVR-nr: 38486160 / Sply Tech ApS: CVR-nr: 38722662