Clinical Trial Application (CTA)

Our services along the whole product lifecycle

Services by stage

Discover all our Drug Development services

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

EU MANDATORY REGULATION

The EU Clinical Trial Regulation enables sponsors or their designees to submit all regulatory documents via a single online platform (CTIS – Clinical Trial Information System) with the aim of generating a harmonized review across all EU member States.

ADVICE AND SUPPORT

RPN provides a broad range of services and solutions, including:

Advice on Trial Design, by capturing both regulatory and market access perspectives.
Selection and coordination of clinical CROs and CMOs.
Advice on EU Clinical Trial Regulation and support for submissions via CTIS.
Regulatory and scientific writing support for the preparation of the CTA-related documentation (Protocols, Investigator Brochures, IMPDs, patient information, and consent forms).
Local Regulatory Authorities and Ethics Committee liaison.

Pharmaceutical & BioTech