we help you explore new ways
to deliver your pharma and biotech projects.

 

PRODUCTDEVELOPMENT.

We establish an ambitious and robust project plan to drive your project on time and on budget. Product requirements captured in a Target Product Profile (TPP) help build a robust pharmaceutical development strategy based on Quality by Design (QbD) principles
Transparent risk and issue management supports communication with your internal stakeholders.

TECHTRANSFER.

A concise and complete request for proposals (RfP) is a prerequisite for effective vendor selection and contract negotiation. Targeted knowledge transfer to your external partners ensures timely and cost-effective supply of drug substance and drug product.
Subject matter experts (SME) support supplier audits and qualification.

REGULATORYAPPROVAL.

We set up a development plan with your regulatory strategy in mind. Validate your approach through early and close 
interaction with regulatory authorities and experts. Build a robust dossier to expedite regulatory review.
Prepare for product launch and roll-out and ensure uninterrupted commercial supply by negotiating with your vendors in good time.