Medica Innova (We), established in late 2006 and located in Bangkok, is the first Thai own "Contact Research Organization (CRO) Plus" providing drug development services to Thai and International Pharmaceutical companies. We have now officially received OECD-GLP Compliance Status, recognized by Bureau of Laboratory Quality Standards, Department of Medical Sciences, Ministry of Public Health, Thailand. In addition, we have been approved to be in the list of NPRA Compliance Programme for BE centers in Malaysia. We would like to take this opportunity to introduce one of our areas of expertise, we have a broad knowledge and experience in Clinical Development from Phase I-IV including BA/BE studies. At Medica Innova, all clinical trials including the BA/BE studies are conducted in compliance with the Good Clinical Practice (GCP) to ensure the quality of the trials especially the right, safety and well-being of subjects as well as the data credibility. Furthermore, we have an in-house bioanalytical laboratory for the sample analysis. All assays are processed according to the current US-FDA and EMA guidelines with Good Laboratory Practice (GLP) applied. We recognize the tremendous benefits in quality management throughout the activities. An internal quality control (QC) and quality assurance (QA) are routinely implemented to assure clients the validity of the study results. We have over 500 healthy volunteer database for conducting BE studies. We could offer you the following services: in vitro dissolution testing, sample size calculation, study design/protocol/CRF/ICF development, project management, EC submission/site management, site monitoring, data management statistical/pharmacokinetic analysis (both noncompartmental and compartmental analysis), development of bioanalytical/clinical study report
METROCHEM API PVT LTD is an ISO 9001:2008 & WHO-GMP Certified Company and vertically integrated manufacturer of API's, Pellets & Intermediates in Multi Therapeutics segments like Antiulceratives, Antifungals, Antidepressants, Antihypertensives, Antithrombotic, Antihistaminic, Antilipemic, Antiarthritic, Anti-inflammatory, Antidiabetic, Antibacterial, Gastroprokinetic etc.. Our facilities are approved by USFDA, COFEPRIS and our facilities inspected by KFDA and moving towards EDQM & COS certifications.