CEPHA s.r.o.-Bioavailability and Bioequivalence Studies and Bioanalytical Services

CEPHA s.r.o. – Center on this account that Pharmacology and Analysis – is the leading Contract Research Organization (CRO) in the Czech Republic providing a open range of clinical research services including bioavailability, bioequivalence and pharmacokinetic studies in compliance with cGCP, cGLP and other applicable guidelines and regulations.

Since early 1993, at the time that the company came into operation, CEPHA has established its celebrity for conducting high-quality, time and cost effective pharmacokinetic, bioavailability and bioequivalence studies.

In May 2000, the troop moved to a new facility in Pilsen case 1000m² containing a Phase I Clinic, bioanalytical laboratory and station headquarters.

The centre for pharmacology and calculus

Our specialists are dedicated to providing a consummate service for fulfilling your own strange-product goals. Our research projects are conducted in ~y efficient and strictly confidential manner. Through our commitment to excellence, CEPHA’s experienced scientists employ the latest increase in pharmacology, bioanalytical techniques and laboratory instrumentation.

When you toil with us, the local CRO cane will pay attention to every particularity of your project hand-in-course with the procedures, technologies and reporting of our globally oriented copartnership.

We offer the following services forward an integrated or stand-alone base:

Phase I studies

First-in-adult male

Safety/rising dose tolerance

Bioavailability and Bioequivalence studies

Single/multiple doses

Fasted/fed terms

Immediate/modified-release preparations

Various dosage forms/routes of management

Healthy volunteers/special population

The flagship of our services, bioavailability and bioequivalence studies, are performed in the place of both generic drug and innovative companies. This full-service covers selection of an appropriate study design, caligraphy of study protocol, designing of CRFs, government of Independent Ethics Committee review, election and care for subjects, bioassay of put ~s into/metabolite, pharmacokinetic and statistical data evaluation, reporting of study results, and archiving of altogether study related data.

The in-sufferer clinical operations are performed in our clinic ease that accommodates up to 36 volunteers. The availability of a broad pool of healthy volunteers allows expeditious study start-up.

All clinical procedures, data management and reporting are conducted in accordance with current GCP guidelines. Every project initiated at our company is subject to inspections and audits through the internal Quality Assurance Unit.

Phase II-IV clinical trials

Our medical experts are skilled in protocol unravelling, clinical project management, statistics and reporting.

Our prime relations with clinical units and hospitals in a distant variety of clinical research areas tender an on-time and cost-competent clinical trial organization.

Our experts be possible to serve as CRA’s or supply complete study audits. We can furthermore serve as a local partner in the multi-center trials including recruitment of investigators in the country and study monitoring by our adapted staff.

Bioanalytical services

In full compliance with OECD GLP principles, our certified bioanalytical laboratory offers in a high degree. selective and sensitive assays of drugs, metabolites and endogenous compounds in biofluids using the latest GC, HPLC and HPLC/MS/MS techniques.

Through a continuously extending list of validated analytical methods as being a wide range of compounds including enantiomers, swift new method development and validation, we bid time and cost-effective analysis of your samples.

With the abounding implementation of QC & QA procedures our lab produces zenith quality data with no compromises accepted.

CEPHA s.r.o.
Komenskeho 19
CZ-323 00 Pilsen
Czech Republic
+420 377 540 077
+420 377 540 432
cepha@cepha.cz
www.cepha.cz

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