Regulatory Affairs

Why us

A comprehensive and customized package of services to manage regulatory affairs activities and to optimize market access maximizing the value of your products

Regulatory affairs

From clinical development to marketing application and to the post-marketing phases, our services streamline and speed-up the pathways to make your product safely available on the market with the highest compliance with applicable legislations governing the Pharma, Biomedical, Cosmetic and Food Supplements Industries. We have experience in supporting small, medium and large enterprises by delivering customable services targeted to the needs of each Organization.
Our Regulatory Affairs services are thought to be strategy-based since the early phases of the product development.


Early development

Early development

at this stage we help our Client to move from
research to product development by defining the best development pathway.This is a strategic and operational service delivered by a staff with experience with national and European procedures.

Late-stage development and Marketing application

Late-stage development and Marketing application

at this stage we support our Clients in preparing for the MA Application and provide guidance on post-market local requirements, worldwide. Among all, our experience encompasses Orphan Drug applications, scientific adivice, generic applications, PIP, Risk Management Plan and minimisation measures.

Launch

Launch

exploring market Regulation and advicing our Clients on how them may affect your product. We help our Customer to be ready for product launch by achieving the highest level of regulatory compliance within established milestones and optimizing the product delivery timing to patients.

Marketing Authorization Maintenance

Marketing Authorization Maintenance

once the product is authorised we provide full regulatory affair support to our Customer to continuously maintain updated documents, systems, agreement related to its products and monitor the legislations regulating them.

More in detail

Brochure

Support for start-up

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Support for Pharmaceuticals

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Support for Medical device

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Pricing & reimbursement

Global support

Through our network of consolidated partner and agents we may support you in all the European Union Territory by coordinating you P&R strategy.

We help you succeed

Our services

  • Preparation of P&R dossier;
  • Managing P&R applications;
  • Managing Negotiation phases;
  • Liason with Regulatory Authorities;

Market access

Our Market Access service starts by listening to our Costumer, its needs and goals.

To do that, and thanks to a multi-disciplinary staff, we propose a customized package of services:

  • Market Research & Analysis;
  • Value-based strategy; 
  • Mapping Key Opinion Leaders;
  • Start-up strategies;
  • Support HTA analysis;
  • Defining pricing strategies.
International activities

Our Network

Experience | Skills | Know-how

We strongly believe this mix is essential to provide a high quality service. For this reason we combine internal resources with a network of professionals to provide you with a Regulatory Intelligence and specific background for the service you are looking for. We are proudly a member of REGULANET®, a network of professionals to support you worldwide.

Such an international Regulatory Intelligence network operates in more than 90 countries including all Europe, China, US, Canada, LATAM, Russia, Australia. It offers services to a wide variety of national and international healthcare and pharmaceutical clients. The members of the network provide advice and assistance on national and international projects and marketing authorisation procedures, including the decentralised, mutual recognition and centralised procedures within Europe

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GB Pharma Services & Consulting Srl Codice fiscale/P.IVA 01900980184
GB Pharma Srl Codice fiscale/P.IVA 02183430186