Excellent Knowledge BA/BE (Bioavailability/Bioequivalence) studies for various Regulatory Agencies.
Experience in Preparing of protocols and Performing and handling various activities related to conduct of Biostudies for oral solid dosage form both Immediate Release and Modified release.
Communication with CRO for clinical study related activities
Clinical Studies monitoring at various CROs as per different regulatory market requirements
Monitoring of the adhesion/irritation and BA/BE studies and Verification of the all study related documents like IEC approval documents, screening records of volunteers, ICF presentation & documentation records, CRF, & IP accountability record etc., according to the regulatory requirements of agency.
Evaluation of Biopharmaceutics review / Dissolution Testing condition /Biorelevent Media selection.
Evaluating the various pharmacokinetic parameters.
Evaluation of Bio equivalence results and comparing it with in-vitro testing data.
Preparation and maintaining the records of summary report of the monitoring.
Reviewing of BE Reports as per regulatory requirements.
Handling various activities to get approval from the DCGI in order to conduct the study in India.
Handling various study related queries from the regulatory agencies and providing them solutions in timely manner.
Preparing compilation of various eCTD modules for EU/TGA / ANDA submission
Handling various project management related activities related to CRO s and Biostudies.
Handling of Investigational Medicinal products .
Medreich is a pharmaceutical company that has been in existence since 1976, manufacturing generic and branded drugs in several therapeutic areas. With more than 2900 employeeÃ¢â‚¬â„¢s worldwide, exceptional quality standards and a client base that is spread across 54 countries, Medreich has built a reputation for raising the bar on product superiority with every undertaking.
Medreich's Research & Development and manufacturing facilities have received the seal of approval from leading global regulatory bodies such as -UK MHRA, Australia TGA, SA MCC, Health Canada, French FDA. The company produces drugs for leading, global pharmaceutical companies such as GSK, Pfizer, Sanofi Aventis, Wyeth, Merck, among others.
Medreich has 8 manufacturing facilities built to comply International regulatory standards. Two newly added facilities are State of the art technology driven plants. One among them has the capacity to produce 9 billon tablets and capsules per annum.
Contact Company:Medreich Limited