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Regulatory Pharma Net

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Regulatory Pharma Net

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/

Revision of SmPC, PIL and labelling / PIL Readability Testing

RPN offers vast services in connection with product and patient information. We can support your company in the preparation, translation and revision of summaries of product characteristics, labelling and PILs, as well as adaptation to QRD format.

RPN has wide experience in the readability testing:Full readability test execution (protocol development, recruitment and interviewing, preparation of the final report to be included in module 1.3.4)Preparation of justification for exemption from readability testingSupport in the establishment of applicable 'bridging strategies'Preparation of bridging reports

Biocides, Food Supplements and Cosmetics

We provide various services to help our clients with biocide, food supplement and cosmetic applications.

BiocidesRevision of the available documentation according to the current regulations to apply for authorisation, preparation of the application, submission and follow-upSupport in the switch from PMC to biocide: documents revision, submission to the authorities and procedure management, including support to answer the comments received by the authoritiesFood supplementsIdentification of the claim that can be used…

Dossier Preparation and Regulatory Procedures Management

RPN staff has wide experience in the preparation of registration dossier and management of the relevant procedures (marketing authorisation applications, variations and renewals).

Support for the preparation of registration dossiers including critical sections (e.g. pharmacovigilance system master file, risk management plan, environmental risk assessment)Advise on different requirements for the submission of marketing authorisation applications (e.g. number of paper copies, electronic submission, content of module 1 etc.)Assistance in writing response documents to authority deficiency letters/list of questionsAssistance in updating…

Medical Devices

RPN is proud to deliver an extensive range of activities and services for medical devices:

Advice on the current legislation on medical devicesRegulatory support for the development of new medical devicesWriting and/or revision of technical dossier to obtain CE certificationManagement of the certification procedure and contacts with the notified bodiesRequest of free sales certificatesRevision of promotional materialAdvice on clinical trialsVigilance servicesManagement of the national medical device database

National Support for Market Access

RPN values the importance of understanding clients’ commercial needs, as well as key decision-makers and routes to market. Our analyses work to establish regulatory and market access solutions, which can quicken clients' products to market, therefore maximising value.

Market access servicesWe provide advice and assistance for compliance with the local requirementsWe seek to improve promotional materialWe provide assistance in compassionate-use programmes 

Pharmacovigilance Services

RPN offers comprehensive services within the pharmacovigilance area, from system establishment to daily maintenance activities.

Pharmacovigilance System Master File (PSMF)Gap analysis of the company pharmacovigilance systemSOPs preparationPSMF preparationPSMF maintenance (planning and management)Pharmacovigilance system maintenance activities (local and EU level)Registration of a RPN representative in the 'Rete nazionale di Farmacovigilanza' (RNF) as local contact person who refers to the EU QP PVRegular check of any report of suspected adverse drug reaction…

Pricing and Reimbursement

RPN provides the following pricing and reimbursement services:

Preparing national price and reimbursement applicationsNegotiating with the authoritiesCoordinating the price and reimbursement applications in EU countries

Quality Management

RPN can support your company in the optimisation of your quality system and audit/inspection preparation, through the following services:

Preparation of SOPs, working documents and ad-hoc quality systems (in line with GMP, GDP, GCP, GVP, ICH Q10, ISO 9001, ISO 13485)Review of manufacturing facilities/processes, quality systems and relevant documentationAudit/inspections support and preparationPreparation of the responses to audit/inspection findings, including corrective/preventive actions (CAPA)Audits of contractor facilities for supplier selection or GMP complianceAudit/inspection readiness trainingInternal auditQuality…

Support During Development Phase

We provide professional regulatory affairs assistance throughout all phases of development.

Methods of supportRegulatory revision of development plans. RPN's team of qualified consultants can assist you towards a smooth and timely pathway of regulatory approval. We will also assess your scientific data to identify any deficiencies, as well as help you plan future studiesScientific advice request. We provide assistance throughout the preparation of supporting documentation and…
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