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.
- ANDA Withdrawals
- ATMP / Cell and Gene Therapy
- Clinical Trial Applications
- CMC Services
- Global End-to-End Outsourcing
- Global Procedure Management
- GxP Services
- Health Authority / Agency Interaction
- Healthcare Compliance and Medical Approval
- MAA / NDA Submissions
- Mergers and Acquisitions (M&A) Transfers
- Scientific, Regulatory and Technical Writing
- Tobacco and Vape Products
- Toxicology Services
What our clients say
Worked with us and our contractors to help us achieve our tight targets, operate with our systems and procedures and are considered invaluable part of our team
VP Regulatory / Quality
Our project team were very impressed with the quality of the research and the reports that you sent through. We didn’t need any convincing that your recommendations should be followed. It showed PharmaLex in a very positive light, and the Project Team are keen to work with you again.
Head of Medical Writing and Publications