M bioserviceS GmbH is an independent consultancy firm with 20 years of international experience in sourcing, logistics, and regulatory affairs supporting biotechnology companies. They help answer questions related to finding, assessing quality, and importing/exporting human and animal biologic raw materials. Their services help biotechnology companies dealing with fluctuating availability and prices of raw materials and changing legislation internationally. They provide tailored solutions to access new sources, obtain rare materials, enter new markets, design transport logistics, and provide regulatory support for import, export, and registration to help with product and business development.
2. M bioserviceS GmbH:
Independent consultancy firm
20 years international experience in
Sourcing, Logistics, Regulatory Affairs
Supports Biotechnology companies in
solving specific Problems related to
human and animal (biologic) raw materials
Who we are
3. We answer questions like:
- WHERE do I find biologic raw
materials?
- WHAT do I know about the source?
- HOW do I recognize good quality?
- WHO helps with import, export or
registration?
What we do
4. Who needs this
- Researchers
- Cell culture users
- Pharma companies
- IVD manufacturers
- Manufacturers of medicinal products
- Cosmetics manufacturers
5. The Challenge
Biotechnology companies use biologic
components in the manufacturing process
These products must perform in a
CONSTANT and RELIABLE way…
…in a continuously changing
Market environment
These products must perform in a
CONSTANT and RELIABLE way…
6. The Challenge
Raw materials are subject to
Availability and
Price Fluctuations
Legislation Changes
in the EU and worldwide
create hurdles and roadblocks
7. The Solution
- we help when
availability and prices are fluctuating
- we help when
laws and regulations are changing
- we help when product
and market intelligence are required
8. The 6 Benefits
• Access to new raw material sources
• Supply of rare biological products
• Entry into new markets
• Individually designed transport logistics concepts
• Regulatory support in import, export and
registration
• Tailored solutions for product and business
development
9. 20 years of experience in the field
of Biotechnology:
Global Regulatory Affairs Manager
at GE Healthcare (past)
Global Sera Business Director
at PAA Laboratories GmbH (past)
Member of BOD at the
International Serum Industry
Association (ISIA) (past)
Member of the Animal
By-Products Task Force
at the European Diagnostics
Manufacturers Association (EDMA) (past)
Member of
www.mbioservices.com
Who‘s behind: Maria Seriakov
Founder / Managing Director of M bioserviceS GmbH