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About us Regulatory Other Services Contact Us
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New Product
Registration in India Preparation of Regulatory dossiers Getting Approval for conducting Clinical trials, Bio-equivalence studies Liaising with the Drug Controller General’s office for obtaining Marketing Authorization for new drugs Clinical Trials Developing protocol, CRF and investigator brochure Investigator selection and finalization Getting ethics committee’s approval Coding, and dispensing of samples to investigators Co-ordination with the investigators for patient enrollment. Responsibility for successful completion of clinical trials Analyze and prepare trial reports Responding to regulatory agency’s request for information pertaining to product safety Bioavailability/Bioequivalence Studies Organising and supervising bioavailability/bioequivalence studies in CRO’s certified by Europe Ages, MCC, WHO and DCGI India. PSUR Relevant literature data for PSUR reports Literature Searches Literature searches on any topic Thorough, accurate, and representative coverage of all the available literature Doctor Queries Response to doctor’s queries based on relevant published data Documentation Services Compilation of MS Word documents from PDF, Scanned text etc. Documents spell checked and proof read Formatted as per client’s requirement Liaison Services Liasoning work for international pharmaceutical companies in India to:
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