From Research to Market
Supporting successful development of
Biopharmaceuticals, (In vivo) BioDiagnostics and Medical Systems from R2M
Turn your innovative ideas and first research results into optimal, robust and better products by using our expertise!
- Substantially increased Probability of Technical Success
- Shorter time to market (shorter R2M)
- Reduced product & process development costs
- Higher profits driven by earlier market entry
Our core consulting competencies in the biotechnology area at a glance:
The products: CHO & E. coli derived products, recombinant proteins (monoclonals, enzymes, hormones, cytokines), fermentation,
protein purification, protein modification, protein conjugation and labeling (random and site-directed)
The processes: Bioprocess development, process scale up, process characterization and validation, process transfers, tailor-made bioprocess
development strategies from "Entry into Human" up to "Filing and Launch"
- The quality: Adaption of bioprocesses to cGMP and to filing and inspection readiness,
- The technical regulatory aspects: Support of technical regulatory strategies and activities (CMC bioprocessing part) from "Entry into Human" up to "NDA / BLA filing"
- (In vivo) BioDiagnostics
- Medical Systems based on Biopharmaceuticals and (In vivo) BioDiagnostics
- Reduced risk
- Shorter R2M
- Lower costs of products and of respective production processes
- Higher profits
Consultancy and Guidance
We offer our excellent technical know how for the focused and cost effective development of marketable products. We offer guidance, support you to follow through with implementation and open doors within our network. Our core areas of our consulting expertise are:
- Technical R&D for products and processes in the Biopharmaceutical & Biotechnology arena
- Establishment and scale up of biotechnology production processes (under non-GMP and cGMP) for these products
- Biopharmaceuticals' CMC part for regulatory approval of products and respective production processes
- Marketing and promotion
We support investors in their investment decisions. We identify and judge the better product in particular with respect to uniqueness, robustness, technical feasibility and probability of technical success. We give you advice for product and process improvements. And, we offer our assessments with respect to technical background and industrial experience and provide you with a roadmap towards implementation and regulatory approval.
Our support for your successful product launch:
- Project Management
- Cost / Benefit evaluation
- Trade show participation
Dr. Josef Burg
BioPharmaceuticals & BioDiagnostics Expert
Josef Burg is a biotechnology & biochemistry expert with wide-ranging experience in TechRes & TechDev to bring BioPharmaceuticals and (In vivo) BioDiagnostics from research to market. He has a profound knowledge of biotechnology/ biochemistry from the ground up. He studied chemistry and biochemistry in Bonn (Germany) before embarking in the BioDiagnostics & Biopharmaceuticals industry 27 years ago. Under his management responsibility he successfully built-up organisations from scratch with up to 300 co-workers in technical development and commercial manufacturing for BioPharmaceuticals. He took responsibility as the production head for BioPharmaceutical APIs according to German Drug Law for 6 years resulting in deep insights in regulations in cGMP and for commercial products. During his professional career he essentially contributed in the bioprocess development part to get several BioPharmaceutical blockbusters to market approval.
Volker Josel brings more than 20 years of experience in product management to our company and our customers. He acquired his excellent expertise in the strategic product management in various leadership roles within the chemical and photographic industry. His studies and career included study visits and international positions in Helsinki, Lisbon and Zurich. In 2008 he founded vobiscon, a company successfully offering product management services and support in project management. His focus is on product management for LifeScience, Software and capital goods within the B2B environment. He is open minded and fond of innovation and fresh ideas.
Ideas, suggestions or questions?
Please do not hesitate to send us your inquiry.
medicondia UG (haftungsbeschränkt)
+49 / 89 / 8908 4051Cell Phone
+49 / 163 / 8911 449
medicondia UG (haftungsbeschränkt)
Tel: +49 / 89 / 8908 4051
Mobil: +49 (0) 163 891 1449
Register court: Amtsgericht München (Munich local court)
Register number: HRB 203366
Authorized Managing Directors: Volker Josel, Dr. Josef Burg
VAT Identification Number (according to § 27 a Umsatzsteuergesetz): DE285972350
Responsible for Content (according to § 10 passage 3 MDStV): Dr. Josef Burg / Volker Josel (address as mentioned above)
Webprogramming & Webdesign: www.burgardsoft.de
According to German law and jurisdiction the party responsible for content may also be responsible for the content and design of the pages linked. This only can be avoided, when the party responsible for content distances itself expressly from all contents and designs of all pages linked.