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More than 25 years of
clinical research experience
Headquarters
- Harpstedt – Germany
Bio-analytical Services
- Bucharest – Romania
Clinical Research Centers
- Dedicated Clinical research unit in Romania
- Phase I-IV Units in Romania & Moldavia
3S Pharma is a Contract Research Organization (CRO) Group providing a complete range of clinical development and bio-analytical services
100 MEMBERS
of staff involved in clinical studies, of which more than half are University graduated scientists (medical doctors, pharmacists, biologists, etc.).
Over 40 full time employees
are involved in bio-analytics, some of them with more then 25 years of experience while others being young, enthusiastic followers.
HPLC-MS/MS
Our bio-analytical laboratory is specialized in HPLC-MS/MS (high sensitivity instruments for small and large molecules) and ICP –MS (Fe, Zn, strontium determinations, etc.).
Over 1000 studies REGISTERED
in EUROPE and USA as well as: Canada, New Zeeland, UAE, Australia, MALAYSIA and TAIWAN.
MORE THAN 1000 STUDIES
In all these years of activity our companies have carried-out more than 500 studies for customers located in 3 Continents and more than 20 countries (Germany, Italy, France, as well as other EU countries, Canada, India, etc.).
(PK) and biostatistics
An internal unit of Pharmacokinetic (PK) and biostatistics take care of the PK data handling and processing.
PUBLICATIONS
A sustained scientific activity is performed by our researchers as proved by a series of relevant publications in international peer reviewed journals and by the participation to public research projects in cooperation with other institutions (Universities, National Research Centers).
100 MEMBERS
of staff involved in clinical studies, of which more than half are University graduated scientists (medical doctors, pharmacists, biologists, etc.).
Over 40 full time employees
HPLC-MS/MS
Over 1000 studies REGISTERED
more than 1000 studies
PK and biostatistics
publications
WHAT
WE DO BEST
CLINICAL RESEARCH
Clinical studies performed by 3S in Romania as well as in Moldavia were inspected by different European Authorities: French, Dutch, German, Austrian, Romanian, Danish on behalf of EMA, etc.; Moldavia also by FDA.
CRO & SMO SERVICES
Meeting the highest quality standards for protocol compliance, patient follow-up, and ip accountability
BIO - ANALYTICAL SERVICES
Our senior researchers have more then 25 years of experience in bio-analytical and mass spectrometry, working with:Small molecules; Peptides; Large molecules; Chiral compounds.
3S
PHARMA
Our bio-analytical laboratory is specialized in HPLC-MS/MS (high sensitivity instruments for small and large molecules) and ICP –MS (Fe, Zn, strontium determinations, etc.).
In all these years of activity our companies have carried-out more than 500 studies for customers located in 3 Continents and more than 20 countries (Germany, Italy, France, as well as other EU countries, Canada, India, etc.).
A sustained scientific activity is performed by our researchers as proved by a series of relevant publications in international peer reviewed journals and by the participation to public research projects in cooperation with other institutions (Universities, National Research Centers).
NEW !!! Our LC-MS/MS lab is quantifying nitrosamine impurities in human medicinal products!
If you want to determine nitrosamine impurities in your products contact us TODAY!As per the requirements of the Regulation (EC) No 726/2004, Article 5 (3) all MAHs/Applicants of human medicinal products should ensure that the presence of nitrosamine impurities in their medicinal products is at or below a limit defined based on ICH M7 (R2)
The published CHMP Article 5(3) opinion together with the Q and A document EMA/409815/2020 Rev.20 are now in force replacing the older letter EMA/189634/2019.
If according to these new documents you need to quantify the nitrosamine impurities in any of your products we can be of help.
