SERVICE
Regulatory Affairs
Comprehensive and Customizable Services to Optimize Market Access and Maximize Product Value
We provide tailored market access solutions designed to maximize the value of your pharmaceutical, biotech, medical devices, food supplements and cosmetics. Our services combine regulatory strategy, pricing & reimbursement expertise, and market optimization to support your products throughout their lifecycle and ensure successful market entry.
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 pharmaceutical, biotech, medical devices, food supplements and cosmetic 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 in line with the regulatory local legislation in force.
IN DETAIL
Our regulatory support for drugs
Our solutions are geared to provide you with a smooth and accurate process to put your drug on the market and to keep 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 Marketing Authorization
Due Diligences
GMP Support
Technical Writing
Risk Management
Regulatory harmonization and work-sharing procedures
Risk Management
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 Advice
Start-up activities and local requirements
Additional services
Scientific Service
Protocol Assistant / Scientific Advice
Orphan Drug Designation
(EMA, FDA)
Pediatric Investigation Plan
(PIP)
Clinical Trial Application
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
Negotiation Phases Management
Follow-up 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.
REGULATORY AFFAIRS FOR
Medical Devices, Food Supplements & Cosmetics
MEDICAL DEVICES
CE marking process and CE certificate renewal in accordance with MDR Regulation (EU) 2017/745, including medical device classification.
Preparation/update of the dossier (Global Technical File) in line with the requirements and sections set out in the new Regulation / MDCG guidance.
Assessment of packaging materials and artwork compliance.
EUDAMED database registration and management.
Drafting of the Clinical Evaluation Report (CER) in collaboration with a team of medical, regulatory, and safety experts.
FOOD SUPPLEMENTS
Artwork drafting
Selection of compliant claims
Technical and scientific support
Safety assessment
Food supplement notification
COSMETICS
Preparation of the PIF (Product Information File)
CLV Cosmetics Certificate
Selection of compliant claims
Technical and scientific support