REGULATORY AFFAIRS
Whether your new product is a drug, medical device, biologic or even a combination of them, we have the up-to-date regulatory expertise to address your specific requirements, across the entire lifecycle
From clinical development to marketing application and to the post-marketing activities, our services streamline and speed-up the pathways to make your product safely available on the market compliant with applicable legislations governing the Pharma, Biomedical, Cosmetic and Food Supplements Industries.
Our Regulatory Affairs services are thought to be strategy-based since the early phases of the product development.
- Strategic development plans
- Regulatory strategy
- Scientific Advice
- Pre-submission meetings
- Liason with Health Authorities
- ODDs/PIPs
- Full Marketing Authorization Application support
- Variations and Renewals
- Launch preparation
- Lifecycle Management
- GMP support
- Maintenance authorization support
International Services
Up-to-date know how + Skills + local experience
This mix is essential to provide a high quality service. We provide you with up-to-date global know-how coupled with local experience, by combining internal capabilities with a network of regulatory professionals.
Our experts also are authorities in the new European Clinical Trial Regulation currently being implemented.
Regulatory Support For Start-Up companies
Solutions to drive innovation
Are you a Start-up planning to enter the European Union market or to expand your business within it? 3B Biotech may be your strategic partner, ready to help you at any stage of your inquiry.
STRATEGIC ADVICE
We provide strategic advices to maximize the speed to market of your products and plan all the regulatory and legal aspects to ensure the highest level of compliance in respect to EU legislation.
REGULATORY SUPPORT
We manage all activities related to MA application and maintenance, assuring local regulatory requirements within the EU are met and speeding up time to market of your products.
ACTING ON BEHALF OF YOUR COMPANY
3B Biotech acts on your behalf towards the EMA and national Competent Authority to manage regulatory procedures.
Regulatory affairs for medical device
3B Biotech may develop a complete project for you or assist your team in the CE marking process, by helping with the increased request for quality clinical data and compliance with the new regulations. Here some duties we may help with:
- Strategic consultancy on the project: feasibility, costs, timing
- Development and implementation of risk management processes and activities
- Checking and/or review of the Technical Documentation according to the latest MDR requirements (including clinical assessment, risk analysis, labels and/or instructions for use)
- Organization of the submission with the Notified Body
Regulatory affairs for pharmaceutical
Our solutions are thought to be Client oriented and to make your product development run smoothly.
Below is a list of key services we propose our Clients:
MA applications MA transfer Variations and Renewals Post-approval Life-cycle management Due diligences GMP Support Technical writing (ASMF, CTD / eCTD) Risk Management Regulatory harmonization and worksharing procedures Manage activities related to MA application and maintenance, assuring local regulatory requirements within the EU are met and speeding up time to market of your products
Regulatory affairs for pharmaceutical in Switzerland
- Setting up regulatory strategies
- Meetings and management of contacts with Swissmedic
- Preparation of documentation for marketing authorisation in Switzerland (e.g. applications for New active substance, KAS with or without innovation, Art. 13, Art.14 TPA)
- Preparation of required forms/documents for Swiss module 1
- Preparation of documentation for marketing authorization including eCTD-compilation
- Preparation of documentation for post-authorisation filings such as variations, renewals, labelling changes and complete review letters
- Management of applications in Swissmedic’s e-GOV portal
- Application and support in Scientific Advice with Swiss Medic
- Preparation of documentation for post-authorisation filings such as variations, extensions, renewals, labelling changes
- Translation services for medical and technical documentation
Local requirements compliance -
Our Network
Dealing with European and National procedures requires MAH to satisfy requirements at a regional level. We provide you with a Regulatory Intelligence network that help you to identify such requirements and implement a schedule work to achieve and maintain the highest level of compliance.
Below is a list of the processes impacted:
Regulatory legislation Scientific Service Administrative aspects Pharmacovigilance
GMP Support
Our support is delivered with Regulatory experts with a sound GMP background and cover 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 manufacturing documents
- Support for quality issues
Additional Services
Through the sinergy with our Clinical and Medical team, as well as a solid experience, we can support you in high specific topics, such as:
- Scientific advice
- Protocol Assistance
- Orphan Drug Designation (EMA, FDA)
- Pediatric Investigation Plan (PIP)
- Clinical Trial Applications
Toxicology Services
Through a qualified network, 3B Biotech is able to perform toxicity and mutagenicity studies.