mediclincr

  We understand the complexity and importance of  Medical writing  and we have the experts for preparation of scientific documents. Our medical writing team closely works with scientists, doctors and other subject matter experts to create effective documentation that vividly define research results and product's usage to give complete satisfaction to our clients.

  We are committed to provide our expert service for   pharmacovigilance   to monitor, assess and report on the safety of investigational products and detect any change to their risk-benefit profile. We work closely with sponsors, sites and regulators to assure compliance against all relevant reporting requirements. Mediclin provides flexible solutions to meet the needs of regulators. Our systems and processes have been specifically designed to meet the needs of the full gamut of sponsors. Our services include: Individual Case Study Report (ICSR) Signal detection Periodic reporting Risk-benefit assessment Medical monitoring

  We are committed to our clients to provide our expert service for   Drug Regulatory Affairs worldwide . We have a team of dedicated experts on Drug regulations who are basically responsible for your products registration, approval and International regulatory arenas through all phases of the drug-development process. We offer extensive industry experience shaping project plans to meet diverse regulatory requirements. Our experts strategize the most efficient route for your product, from Bio analytical study requirements, pre-IND/pre-NDA meetings, and applications to Competent Authorities and Ethics Committees, to successful marketing applications, while providing the necessary guidance to ensure continual regulatory compliance. We provide worldwide Regulatory Services including: Fast local regulatory approvals Regulatory with respect to IMPs Imports/Exports Expedited submissions of Regulatory dossiers Regulatory with respect to Bioequivalence & conduct clinical trials of new drug

  We understand criticality & importance of Clinical operations in all scientific studies. From start-up to close-out, our highly skilled clinical operations teams ensure proper planning, conduct, patient safety, and data quality, while fostering good communication between study sites and sponsors. This all comprises to timely closing the projects with sponsor requirements with respect to projects.

  Mediclin Clinical Research is a leading Global Contract Research Organization (CRO) based in Mumbai. We are end to end clinical trial service provider supporting comprehensive drug development and product lifecycle management. Our clients and partners include pharmaceutical, biotechnology, medical device, and government organizations. Our therapeutic expertise and a firm commitment to quality, integrity and ethics to help our clients and partners bend the cost and save lot of time of drug development and optimize value in delivering life-changing therapies to improve health.