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Home > Our Services > Integrated Product Development

Integrated Product Development

Discovery Phase to Market Authorization / Approval

Today’s ever-changing regulatory environment requires expertise and innovative solutions to overcome the current and future challenges that all companies face. Our aim is to help our clients achieve marketing approval and commercial excellence.

PharmaLex extensive product development consulting services offer support through the product lifecycle from the earliest Discovery Phase, non-clinical and clinical planning and development right through to Market. Our regulatory and development experts can help you define or refine your development strategy, provide toxicology and CMC development needs and support for agency advice (FDA/EMA), orphan drug designation, Pediatric Investigational Plans and drug designations. In addition to small molecules, NCEs, our expert team provide consulting services for development of ATMPs, Biologics and Vaccines, and are specialists in providing Fast Track and PRIME support

We understand that while regulatory approval is a critical step in getting a drug to market, approval does not guarantee market success. Our expert Market Access team are proficient at working closely with our development consultants in providing early Market Access Modelling to ensure that a development strategy will achieve the end goal of reimbursement. A full Integrated Product Development service also requires regulatory support for Clinical Trial Applications / IND submissions, Pharmacovigilance for the clinical development phase and all underpinned with quality management support.

PharmaLex can offer our clients a Program Manager to drive an Integrated Development program. The program manager is a regulatory strategy expert who adds value through extensive development knowledge required to ensure that a program stays on track.

Want to find out more?

PharmaLex. Confidence beyond compliance.

Contact us for more information

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Case Studies

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What our clients say

What was especially important to me was their ability to get a team, with the right experience, together so quickly.

Mid-size Biotech
Head of Outsourcing

Rina and the team were brought in to help support us during the PMCPA complaint process and subsequent audits. Their expertise and approachability made this difficult process smooth. True professionals and a pleasure to work with!

Astellas
Head of Ethics and Compliance, Astellas Pharma Europe
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