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.