Due Diligence

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Drug Development Regulatory Affairs Market Access Pharmacovigilance Quality & Compliance Case Studies

Drug Development

Drug Development Strategy Gap Analysis SME Status Orphan Drug Designation (ODD) Scientific Advice Pediatric Investigation Plan (PIP) PRIME (PRIority MEdicines) scheme CMC Regulatory solutions Clinical Trial Application (CTA) Due Diligence

Regulatory Affairs

Registration Strategy Marketing Authorization Application (MAA) CMC Regulatory solutions Dossier Development Life cycle management Due Diligence Launch readiness Advertising & Promotion

Market Access

Early Access Programs Market Access Strategy Pricing & Reimbursement Dossier Health Economic Models Negotiation with Health Authorities Pricing & Reimbursement maintenance Joint Clinical Assessment (JCA) Integrated strategy and execution in the European markets

Pharmacovigilance

QPPV Services EudraVigilance services Pharmacovigilance System Master File (PSMF) Local Pharmacovigilance

Quality & Compliance

RISK MITIGATION

Licensing or investment decision-making in tightly regulated industries like Pharmaceuticals carries a high degree of risk.

This requires a due diligence process that examines regulatory compliance across a broad spectrum of areas and stakeholders, such as manufacturers and partners, to identify risks and provide guidance on the steps forward.

Items that are typically covered include CMC documentation, Non-clinical and Clinical studies, Post-approval commitments, Sunset Clause issues.

The due diligence output provided by RPN will highlight all the significant concerns and strategic advice.

Pharmaceutical & BioTech