Business consultations on Biotechnology and Life Science industries.
Are you a business owner that is related to the biotechnology and life science industries? Then you are in the right place.
Our experienced team will guide you through the whole science and consult on the things that you need to know to be successful in this industry.
Strong expertise in cell, gene therapy, CAR-t cell therapy, and advanced therapy medicinal products.
Business consultations on these topics and knowledge of medicinal products by our Biotechnology expert Dr. Janis Ancans are based on ten years of expert experience:
- as a member of the European Medicines Agency (EMA) Committee for Advanced Therapy products and Cell product working party;
- professional involvement in the classification and marketing authorization evaluation procedures;
- participation in the drafting process of related guidelines;
- Core member of the Cell product working party (CPWP) at the European Medicines Agency (EMA);
- External expert at The State Agency of Medicines.
This has been followed by professional experience with both public and private sector projects, including business consultations for the European Commission, Government bodies, KPMG, and Voisin Consulting.
Core Life Science Competencies
Serving government agencies
We advise our clients about partnership opportunities and processes with government agencies.Clinical development
Based on our hands-on experience we offer help to understand the specific industry and successfully develop Biotechnology and Life Science solutions.Quality approval
Our team has become highly familiar with the quality indicator by working in the field that requires it in high level. Therefore, we are able to answer quality approval questions to ensure rights to act, promote competitiveness and success.Commercialization
We pass on our knowledge about managing commercialization processes from planning to distribution worldwide, to contribute effective commerce practice.Regulatory
We provide answers to regulatory questions in order to promote suitable operation to requirements.Complications
Our team’s versatile experience allows us to give advice to our customers to avoid problems, obstacles and mistakes which inhibits their productivity.Our expert consultations have helped such public and private clients as:
Advantages and Benefits of Biotechnology & Life Sciences Consulting by Medrego:
- Biotechnology & Life Sciences consulting improves decision making.
- Helps optimize and reduce compliance costs.
- Boosts the innovation process.
- Helps optimize and reduce operational costs.
- Increases the ability to rapidly develop.
References:
“Manufacturing, characterization and control of cell-based medicinal products: Challenging paradigms toward commercial use” (2015);
Regenerative Medicine:
https://www.futuremedicine.com/doi/full/10.2217/rme.14.65
“Regulatory evaluation of Glybera in Europe – two committees, one mission”; (2013),
Nature Reviews Drug Discovery:
http://www.nature.com/nrd/journal/v12/n9/full/nrd3835-c1.html
“Mesenchymal stem cells in solid organ transplantation (MiSOT) fourth meeting: Lessons learned from first clinical trials” (2013),
Transplantation:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3737392/
“Cell therapy medicinal product regulatory framework in Europe and its application for MSC- based therapy development“ (2012), Frontiers in Immunology:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3418507/
“Challenges with advanced therapy medicinal products and how to meet them” (2010),
Nature Reviews Drug Discovery:
http://www.nature.com/nrd/journal/v9/n3/full/nrd3052.html
Share your needs and get a quote.
Outsource your key needs and business expert consultations to be more competitive:
cartcell@medrego.com
+44 20 8144 1888
CAR T-Cell Advisory by Medrego
