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.
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.
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.