Regulatory Affairs

Regulatory Pharma Net – Your Qualified Provider of Tailored Solutions

Founded in 1999, Regulatory Pharma Net (RPN), is a qualified and established, regulatory affairs consulting company based in Italy.

RPN boasts a highly-qualified team of experts, which include internal and external regulatory affairs specialists. These specialists have a multifaceted range of competences in a variety of fields including medicinal products, medical devices, cosmetics, biocides and food supplements.

At RPN, we deliver support through development, registration, launch and lifecycle management.

We are proud to be a regulatory affairs partner to many pharmaceutical companies. We manage hundreds of regulatory multi-task projects, on a worldwide-scale.

A glance at our activities

  • Preparation of registration dossier for marketing authorisation, variations and renewal application
  • Advice on registration strategy and health authority requirements
  • Regulatory submission, procedure management and liaison with regulatory authorities
  • Regulatory due-diligences
  • Clinical trial applications
  • Orphan drug applications
  • Paediatric investigation plan applications
  • Scientific advice and protocol assistance
  • Audits to API and finished product manufacturers
  • Technical dossier for medical devices
  • Pharmacovigilance
  • Price and reimbursement
  • National support for market access
  • Project management
  • Facilitation of local concerns via a network of partners in EU and non-EU

Staff expertise

Our staff have grown considerably, both in number and expertise. RPN's current staff includes:

  • Senior RA Consultants. With ten to 15 years of experience in international and regulatory affairs, as well as R&D, our senior RA consultants possess both academic and industrial experience in an array of multidisciplinary areas. These areas include pharmacy, biology, chemistry, toxicology, clinical, pharmacovigilance. They have also gained vast experience in regulatory project management, in areas such as preparation of registration dossiers, regulatory compliance activities and regulatory procedures management. RPN senior RA consultants are experienced in writing chemical-pharmaceutical, non-clinical and clinical documentation for regulatory submission
  • GMP and Quality Consultants. Our GMP and quality consultants possess more than 20 years of analytical experience, working in chemistry, pharmaceutical and manufacturing facilities. They have built strong relationships with GMP auditors, in carrying out GMP inspections, and have also developed a broad scope of knowledge in an array of areas, including pharmaceutical development, and quality assurance and control. GMP and quality consultants are also aware of how to manage and co-ordinate the preparation of chemical-pharmaceutical documentation for regulatory purposes
  • Regulatory Affairs Officers. Our officers have several years of experience, as well as multidisciplinary academic
    backgrounds in pharmacy, biology and chemistry. They have acquired vital experience in both the preparation of registration dossiers, and the management of regulatory procedures (new registration, variations, renewals). They are also experienced in editing chemical-pharmaceutical, clinical, and non-clinical documentation for regulatory submissions
  • Drug Safety Consultants. EudraVigilance certified for drug safety management
  • eCTD Managers. These managers are experts in managing eCTD publishing software, Extedo. RPN staff can temporarily work at the client sites, according to the client needs

Our partnerships

We have worked hard to establish and consolidate a network of reliable consultancy partners in EU countries. RPN has managed several projects for multinational corporations, acting as EU coordinator consultant. What's more, RPN is proud to have reliable consultancy partners in Switzerland, the U.S., Canada, Australia, New Zealand, LATAM countries, Russia and CIS countries.

Our values

  • A team of hard working, professional experts
  • Up-to-date and accurate intelligence on legislation and cumulative experience
  • Strong focus on client care, tailoring our bespoke solutions to meet their individual needs
  • Building solid partnerships with local consulting companies in other countries
  • Quality management system in place: UNI EN ISO 9001:2008 certification

Our mission

  • To provide our clients with an broad range of services, designed to meet the standards of the regulatory authorities
  • To bridge the communication gap between the companies and the competent authority
  • To deliver the market with regulatory, strategic, and operational support throughout the entire R&D process
  • To drive clients by offering them a unique insight into regulatory thinking, and offer expert guidance to optimise the time to the market

 

Contact details:
Regulatory Pharma Net SRL

Corso Italia
108 - 56125
Pisa
Italy
Phone: +39 050 503 954 / 500 785
Fax: +39 050 220 4315
E-mail: info@regulatorypharmanet.com
Website: www.regulatorypharmanet.com/