1.Measuring drug concentration in human biological sample
Protech Pharmaservices Corporation has provided measuring drug concentration in samples.
We have been ordered over 1000 projects and established over 300 drug analysis validations.
Protech Pharmaservices Corporation's analytical results are accepted in many countries:
Japan,Canada,USA,Australia,Taiwan,China,
Germany,Singapore,Thailand,Indonesia,Malaysia,
Philippines and so on.
We analyze samples with LC/MS-MS and other instruments.
Our central lab is certified by OECD-GLP,TFDA GLP,
we had inspections by FDA,and passed it in 2016.
2.Conducting CRO Business overseas
We collect information about the guideline of each country, regulation and related clinical trial with our overseas network.
PPC has three branch offices (Japan,China,Korea) and five liaison offices(USA,Australia,Singapore,Malaysia,Hong Kong).
We can consult among some countries.
We provide information about marketing research
in Asia-Pacific,matching co-developer,presentation of regulation.
And we can also help to conduct investigator initiated trials and clinical study.
3.Consultaion
4.Managing clinical trials in Japan
If overseas pharmaceutical company which has no office in Japan wants to conduct clinical trials,
we will do it instead of them.
Selecting sites and CRO,managing investigation drugs,
checking protocols,investigator's brochure and other relevant documents and taking out insurance for clinical trial.
We can help to conduct clinical trials in Asia,USA,
and other countries with our wealth of experience.
We will do these things:setting protocol,
approval for IRB,selecting sites,recruiting subjects,
measuring samples.
We have experienced clinical trials in various forms and departments of investigational products.
The details are listed below.
Form of investigation that we experienced:
oral,injection,inhalation,poultice,ointment
Departments of investigation that we experienced:
cardiology,gastroenterology,infection,psychiatry,
metabolic disease,pneumology,cancer
Our trial data are accepted in Taiwan and Malaysia.
And we can help to apply for approval in China.
Now,we are conducting bioequivalence test for FDA,USA and preparing eCTD.