A comprehensive and customizable service package to optimize market access while maximizing the value of your products
Our partnership model is based on the idea of simplifying outsourcing management for our customers. GB Pharma is your Provider during the entire lifecycle of your products
Regulatory Affairs
From clinical development to market release and post-marketing phases, our services optimize pathways to make your products available safely and in full compliance with applicable and current legislation in the pharma, biomedical, cosmetic and nutraceutical sectors.
We have experience working with small, medium and large companies, and provide services that are customizable and targeted to the needs of each Company.
Our regulatory services are strategically designed from the early stages of product development.
Our “plus” comes from a team of regulatory experts with experience in chemical-pharmaceutical, clinical and non-clinical regulatory documentation.
Our regulatory services are strategically designed from the earliest stages of product development.
We help the Client to move from research to clinical product development, defining the best pathway. This is a strategic and operational service provided by a staff with experience in national and European procedures.
We aim to support our Clients in the preparation of marketing authorization application and provide assistance on local market requirements, on a global basis.
In addition, our expertise includes management of Orphan Drug Designation, Scientific Advice, generic drug marketing, PIP, Risk Management Plan and minimization measures.
We explore market regulation and advise our Clients on how it may affect their products. We help our Client to be ready at the time of product launch, achieving the highest level of regulatory compliance within set milestones and accelerating product access for patients.
Once the product is authorized, we provide full regulatory support to our Client in order to keep all documentation, product contracts and monitor the legislation that regulates them up to date.
In detail
Our regulatory support for drugs
Our solutions are geared to provide you with a smooth and accurate process for bringing your drug to market and keeping it there.
Through a pool of clinical and non-clinical regulatory experts, we support you at all stages of regulatory development.
Below is a list of the main services we offer to our Clients:
Marketing authorization applications
(Marketing Application)
Transfer of authorization requests
Variations and Renewals
Management of post-approval activities
Due diligences
GMP Support
Technical writing
(ASMF, CTD / eCTD
Risk Management
Regulatory harmonization and collaboration procedures
Compliance with local requirements
Confronting national and European procedures involves having Regulatory Intelligence to enable you to identify strategy and address the processes involved.
Our support includes:
Regulatory Legislation
Pricing & Reimbursement
Scientific Service
Administrative aspects
Pharmacovigilance
Risk Management
Through the synergy of an in-house multidisciplinary team, we support our clients to promote the safe use of medicines and safeguard patient health through the establishment of an effective Risk Management System. Our experts can help you identify the risks associated with your products and define the most appropriate risk management measures (RMMs)
Support for GMP good manufacturing practices
Our support is provided by regulatory experts with a strong GMP background and covers the following topics:
Evaluation of suppliers of raw materials and finished products
audits to suppliers of raw materials and finished products
evaluation of production processes
evaluation of production documents
Support for quality-related issues
Additional services
Scientific Service
Protocoll Assistant / Scientific Advice
Orphan Drug Designation
(EMA, FDA)
Pediatric Investigation Plan
(PIP)
Clinical Trial Applications
Pricing & Reimbursement
Global support
Through our network of established partners and agents we can support you throughout the EC, coordinating your P&R strategy.
Our services
P&R dossier preparation
P&R application management
Management of Negotiation Phases
Relations with Regulatory Authorities
Market access
Our Market Access service begins with listening to the client and understanding their needs and goals.
Through our multidisciplinary staff we then offer a package of customizable services:
Market Research and Analysis
Value-based strategy
Key Opinion Leaders Mapping
Strategy for Start-up Companies
HTA analysis support
Definition of pricing strategies
INTERNATIONAL ACTIVITIES
Our regulatory support network
We combine our internal resources with a network of professionals to provide the best regulatory support network and background most specific to the service you are seeking.