Transdermal Patches / TDDS / TDS
Transdermal Patch Research: Evaluating PK and adhesion performance
Undoubtedly, there are many innovations and advancements in the transdermal drug delivery system and if you are a company that is looking for a reliable partner, experienced in this type of studies, you found us!
At 3S Pharma we design and conduct studies for locally applied products with systemic action (Transdermal Systems), evaluating PK irritation and sensitization and adhesion performance.
Our scientific methods applied for transdermal patch studies have a personalized design that focuses on the performance of the product, improving patient compliance, and also on the safety of the process and the appropriate feasibility of the product.
Strict regulatory approval for transdermal patches
This might be a challenging road, but using our expertise in these specific transdermal patches studies, we are compliant with the strict requirements for safety, efficacy and quality assurance. We also create specific design studies in order to prove the safety and efficacy of transdermal patch formulations, one of the EMA and FDA strict regulations.
That is why, we conduct and design clinical studies for transdermal patches that meet the key regulatory considerations during the development, testing and approval of the transdermal patches product and also include in the design the GCP guidelines and regulatory requirements to ensure the validity and integrity of the collected data.
For delivering a transdermal patch study with the optimum results, our designs might include:
- In vitro and in vivo drug product performance
- In vitro skin permeation studies
- In vitro adhesion tests (for adhesive properties)
- In vivo adhesion studies
- Pharmacokinetic studies
Specialized proven work
Proven by over 100 audits conducted by customers and third parties,all with positive conclusions and stating GCP compliance.
Clinical studies performed by 3S in Romania as well as in Moldova were inspected by different European Authorities: French, Dutch, German, Austrian, Romanian, Danish on behalf of EMA, etc.; Moldovaalso by FDA.
Tradition and experience
In over 25 years of practice, our team of specialists has successfully managed over 1500 complex international clinical studies.
Proficient in clinical research
We perform early development studies in our dedicated privately owned research facilities in Romania and Moldova, with a bed capacity of 160 units.
We also can provide larger group targeting for clinical trials through our partnership with different hospitals from Romania and Moldova, or other hospitals across Europe with long term confinement from an average of 2 weeks to as long as 8-12 weeks.
Experience and capabilities
Experience with both healthy participants and a special demographic group: recruitment of large groups of healthy volunteers is possible in a very short timeframe. We have a healthy volunteer database of over 10.000 subjects.
This fact emphasizes our capabilities to enroll big groups of healthy volunteers in a very short time, to enroll patients and naive patients on specific stable treatments across Eastern Europe (Romania, Moldova, Georgie, Armenia, Bosnia, etc.).
Also, we obtain very good retention rates in lengthy studies or studies with long-term confinement.
Fast Track Approvals
Experience expedited regulatory approval in Moldova just 2 weeks from submission.
If you want to have a deeper knowledge of what we do, we invite you to contact us!
