MBR Consulting – your partner in Regulatory environment
Regulatory Affairs
When your business needs employees who are highly qualified in the field of pharmaceutical regulatory affairs, we can provide you with extra capacity and know-how. Our professional staff and network can guarantee experienced contact with authorities throughout Europe. We are specialized in regulatory affairs field for human and veterinary medicinal products.
MBR Consulting is a full-service provider for all aspects of regulatory affairs related to medicinal products, medical devices and veterinary products. We also can offer services for cosmetics, food supplements and foods for special medicinal purposes. MBR Consulting offer You support from high level expertise to practical working solutions. Our staff works with you to develop and implement global regulatory strategies, prepare submissions, manage Agency communication.
We are a member of Regulanet® - The International Regulatory Affairs Network.
In 2001 Dr Regenold GmbH founded Regulanet® which is a network of regulatory affairs consultancies with members throughout the world. Led by Dr Regenold GmbH, the members offer services to a wide variety of national and international healthcare and pharmaceutical clients. The network uses state-of-the–art tools to ensure efficient communication and access to information, between members and clients. regulanet® provides advice and assistance on national and international projects and marketing authorisation procedures, including the decentralised, mutual recognition and centralised procedures within Europe.
http://www.regenold.de/HOME/Our-Network/regulanet-
We can offer you:
• Experience
• Professional services
• Deep knowledge of Polish and an International Drug Law and Regulatory environment.
OUR SERVICES IN THE REGULATORY AFFAIRS SECTOR INCLUDE:
- Strategy Planning & Project Management
- Regulatory and Product Development Strategy
- Product Marketing Authorisations and Variations: Strategies and Management
- Pricing & Reimbursement Strategies
- Consultation with key regulatory Agencies and Experts
- Regulatory Submissions
- National, Mutual Recognition, Decentralized Procedure and Centralized Procedures: dossier preparation and filing; contacts with Health Agencies, Experts and Opinion Leaders on behalf of the client
- Manufacturing site authorizations; assistance during inspections
- Clinical Trial applications to Ethical Committees and local Authorities
- Pricing & Reimbursement Applications and Negotiations with Authorities
- Medical Devices, Food Supplements, Cosmetics
- Orphan Drug Applications
- Post - Approval support (Regulatory Maintenance)
- Variations to marketing authorisations - regardless of procedure type and variation classification
- Renewal of Marketing authorization
- Marketing Authorization Holder transfer applications
- Pharmacovigilance activities - ISCR and periodic reports submission - PSUR preparation
- Review of SmPCs, leaflets and labels
- Approval of Promotional activities/Meetings/Promotional materials/Web sites
- Regulatory compliance (GLP, GCP, GMP)
- Legal Representation of MA Holder
- Document and dossier Preparation
- Writing, editing and review of Chemistry-Pharmacy, Non Clinical, Clinical Dossier
- Summaries and Overviews
- Commissioning independent Experts
- Drug Master Files
- Scientific and Technical Translations
- Business Development
- Licensing activities
- Distribution and License agreements
- Due-diligence reviews within acquisition projects
How we can cooperate - full or partial outsourcing?
If you think about outsourcing you can decide how much and when you want to outsource. You can outsource all RA responsibilities or selected projects for which you do not have capacity in-house. You can begin with the basics, and we will put a plan in place to help you transition to a total outsourced solution when you are ready.
Partial outsourcing is a cost effective way to obtain thoroughly qualified and knowledgeable professionals to get assistance in regulatory procedures, document preparation and management.
