R&D to Manufacturing - Our Services

Bioteknowledge can assist your organization and offer expert guidance in these and other areas:

1. •Product Development
   

2. •Project Management
   

3. •Structural/Functional Characterization
   

4. •Drug Stability
   

5. •Assay Development and Validation
   

6. •Computer and Instrument Validation
   

7. •Quality Control (GMP/GLP)
   

8. •CMC Sections/Regulatory Submissions
   

9. •Due Diligence Review/Competitive Assessment
   

10. •QA Audits
    

11. •Technical/Scientific and Regulatory Writing
    

12. •Special Guidance for new and emerging Companies 
    

Scientific Expertise

1. •Large and Small Molecule Analytical Biochemistry
   

2. •Pharmacokinetics and Metabolism
   

3. •Spectroscopy
   

4. •Protein Chemistry
   

5. •HPLC/UPLC
   

6. •Mass Spectrometry
   

7. •ELSIA development and immunochemistry
   

8. •DNA/RNA Analysis
   

9. •Gene Expression
   

Bioteknowledge can also tackle a wide variety of other issues in the development of small molecule and protein drugs and medical devices. Both short-term arrangements and long-term contracts are acceptable. Please contact Bioteknowledge and we will be happy to discuss your needs.