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
- Development Strategy and Gap Analysis
- Global End-to-End Outsourcing
- Global Procedure Management
- Good Distribution Practice (GDP) Compliance
- GxP Services
- Health Authority / Agency Interaction
- Healthcare Compliance and Medical Approval
- MAA / NDA Submissions
- Mergers and Acquisitions (M&A) Transfers
- Orphan Drug Designation
- PDE and OEL Services
- Pediatric Investigation Plan (PIP)
- Scientific Due Diligence
- Scientific, Regulatory and Technical Writing
- Tobacco and Vape Products
- Toxicology Services
What our clients say
There was a close relationship between the regulatory strategy and the writing activities. You developed a fine-tuned regulatory strategy which will be a key factor to smooth the approval of our dossier.
VP Regulatory Strategy
We really appreciate your responsiveness and availability during our previous exchanges and it is what we are waiting for from our partner.
Head of Regulatory Affairs