Our services

Pharmaceutical, Preclinical and Clinical Development

RPN provides professional regulatory affairs assistance throughout all phases of development.

RPN services are:

  • Regulatory revision of development plans.
    RPN team of qualified consultants can assist towards a smooth and timely pathway to regulatory approval. RPN will also assess the scientific data to identify any deficiencies, as well as help the clients to plan future studies
  • Pharmaceutical and Quality development:
    • Definition of formulation and manufacturing process development programs including supervision and final review of results
    • Quality by design and design space planning
    • Scale-up and process validation programs
    • Analytical development programs, review of validation protocols and reports
    • Production and analytical transfer including on-site support
    • Support in selection of packaging materials and Medical Devices for administration
    • Stability programs for ICH and other regions including supply chain requirements
    • Requirements for investigational medicinal products (IMP) manufacture, analysis and distribution
    • Quality part of IMPDs/INDs
    • Modules 2.3 and 3
    • Dossiers for applications for Certificate of Suitability (CEP)
    • Drug Master Files/Active Substance Master Files
    • Review of quality agreements and other GMP documentation (e.g. site master files)
  • Scientific advice request:
    • Provide assistance throughout the preparation of supporting documentation and presentation of the questions and company position, for both national and centralised advice
    • Take care of communications/meetings with the Authorities, even acting on clients behalf
  • Orphan Drug Applications
  • Clinical Trial Applications
  • Paediatric investigation plan (PIP) applications:
    • Advise on the approach for PIP, deferral and/or waiver applications, according to the Paediatric Regulation
    • Support for the preparation of the relevant documentation, submission and follow-up of PIP application
    • communications/meeting with the Paediatric Committee (PDCO)

Liaison with the regulatory authorities

Assist in developing, assembling, reviewing clients’ meeting request package and initiate contact with agencies. Attend meetings with agencies.