Who says you need your own lab?
You order car-sharing rides. You charter a jet. You work with an accounting firm. The smart way is to outsource. We do it in everyday life, so why not do the same in business?
You don’t need your own lab to get results. Labka supplies development and manufacturing support with state-of-the-art equipment and facilities that provide specialised analytical testing for API and drug product development. Choose one of our packages, or have the service tailored to your needs.
You don’t need your own lab to get results. Labka supplies development and manufacturing support with state-of-the-art equipment and facilities that provide specialised analytical testing for API and drug product development. Choose one of our packages, or have the service tailored to your needs.
Testimonials
PRO.MED.CS Praha
Labka’s support of our pharmaceutical development gave us access to advanced analytical techniques otherwise unavailable to us in-house. Labka’s involvement included the reverse engineering of a comparator drug, advanced API characterisation, biowaiver support, and specific analytical method development. The co-operation with Labka was reliable, fun, and it increased the efficiency and accuracy of our development projects, given it was tailor-made to our needs and issues.
Pavel Kovačík
— Director Research & Development
Jagiellonian Center of Innovation,
Krakow
Co-operating with Labka has perfectly complemented the analytical services we provide to our Polish and international customers. With Labka, we’ve combined our analytical expertise with highly focused and comprehension-oriented, industrial analytical designs, allowing us to crack even the toughest analytical nuts brought by our clients into our labs.
Lukasz Kutrzeba, Ph.D.
— Business Development Director
Synavia
Our client requested a reverse-engineering analysis of a reference product for the purpose of Scientific Advice discussion at the initial stage of development. The reference product consisted of 8 excipients, several of which had the contents indicated in the SmPC. The response from Labka was swift and very helpful. The analytical study was performed without delay and at a reasonable cost. It has given satisfactory results, allowing for a complete picture of the reference product’s quantitative composition. Overall, Labka’s approach is prompt, scientifically professional, and, last but not least, friendly and enthusiastic.
Martina Nora Odložilíková
— Independent Consultant
PRO.MED.CS
Praha
Labka’s support of our pharmaceutical development gave us access to advanced analytical techniques otherwise unavailable to us in-house. Labka’s involvement included the reverse engineering of a comparator drug, advanced API characterization, biowaiver support, and specific analytical method development. The co-operation with Labka was reliable, fun, and it increased the efficiency and accuracy of our development projects, given it was tailor-made to our needs and issues.
Pavel Kovačík
— Director Research & Development
Jagiellonian Center
of Innovation, Krakow
Co-operating with Labka has perfectly complemented the analytical services we provide to our Polish and international customers. With Labka, we’ve combined our analytical expertise with highly focused and comprehension-oriented, industrial analytical designs, allowing us to crack even the toughest analytical nuts brought by our clients into our labs.
Lukasz Kutrzeba, Ph.D.
— Business Development Director
Synavia
Our client requested a reverse-engineering analysis of a reference product for the purpose of Scientific Advice discussion at the initial stage of development. The reference product consisted of 8 excipients, several of which had the contents indicated in the SmPC. The response from Labka was swift and very helpful. The analytical study was performed without delay and at a reasonable cost. It has given satisfactory results, allowing for a complete picture of the reference product’s quantitative composition. Overall, Labka’s approach is prompt, scientifically professional, and, last but not least, friendly and enthusiastic.
Martina Nora Odložilíková
— Independent Consultant
Services
End-to-end analytical support
- Advanced API, intermediates (granulate, pellets) and drug product forms characterisation
- Drug product reverse engineering
- Complex comparison test vs reference drug product before the clinical study
- Biowaver support and troubleshooting
- GMP: method development, method validation, routine and stability measurements per specifications
Smart preformulation trials in small scale
- Preformulation experiments – identification of critical parameters
- Small scale formulation experiments supporting the drug product development
- Preparation of drug product forms with different API release profiles
- Stabilisation of API in drug product form
- Patent and troubleshooting support
How it works
Not only do you not need your own lab, you don’t even have to leave your office. At least, not most of the time. We can provide the whole service online, which allows us to help you wherever you are in the world.
However, there are some cases where your personal presence is absolutely necessary. Our experts arrive in person for complicated, hands-on tasks such as troubleshooting.
The Six steps
1.
Online call
(after signing the NDA)
We’ll discuss what needs to be done and why, and do our best to gain a detailed understanding of the project, so we can correctly interpret the results. This initial consultation is free.
2.
Designing the experiments and price estimate
We’ll design the experiment(s) to meet your precise needs and set the price.
3.
Online call
We’ll fine-tune the details and answer any remaining questions from both sides.
4.
Performing the experiments
We’ll run the experiments at our partners’ facilities (universities, development centres), featuring a well-organised system with clear rules and NDAs.
5.
Report
We’ll create a report including the data interpretation and suggestions for further steps.
6.
Teleconference
We’ll present and interpret the results and discuss the outcome.
Labka follows up on the activities of the industry expert Kapaji. It is a unique model of direct scientific cooperation between Kapaji and top academic partners and it has been tried and tested in many industrial projects. The Labka’s scientific team can claim more than 20 years of experience in development of API and drug forms.
Labka follows up on the activities of the industry expert from Kapaji. It is a unique model of direct scientific cooperation between Kapaji and top academic partners and it has been tried and tested in many industrial projects. The Labka’s scientific team can claim more than 10 years of experience in development of API and drug forms.