Pharmopine

Established in the year 2015, PharmOpine offers comprehensive range of medical, pharmacovigilance, medical writing, research and other related services in the field of Pharmaceuticals. Our combined experience of more than 50 years helps you in conducting various studies for Clinical trials, Medical Coding, Medical notes, reviews etc… Our Team is a mix of physicians and pharmacists whose combined experience of more than 50 years in the field of medical and pharmacovigilance activities with in depth knowledge of restorative area. Our team always ensures that the key Criteria’s of Clinical Trials are taken care off and meet the regulatory demands. If required, we are able to provide 24 X 7 technical support to investigators during the Clinical Trials. We can prepare and review all the documents required for clinical trials and prepare or approval by the sponsor. We can also assist the study team before, during and after the study for all medical issues to be taken care off while conducting the study. Pharmopine caters following services to clients:(1) Medical writing (a) CTD Module 2.4 Nonclinical Overview (b) CTD Module 2.5 Clinical Overview (c) CTD Module 2.6 Nonclinical Summaries (d) CTD Module 2.7 Clinical Summaries (e) CTD Module 1.9 Summaries of Clinical Studies (f) Addendum to the clinical overview (ACO)(2) Pharmacovigilance (a) Adverse Event Case Evaluation and Processing (b) Literature search for Pharmacovigilance (c) Narrative writing (d) Risk Management Plans (RMPs)(e) Periodic Safety Update Reports (PSURs)(3) Clinical Trial/Bioequivalence study (a) Provide medical inputs for designing protocol of clinical trial & other clinical trial activities (b) Review of Clinical/Bioequivalence study Protocol (c) Review of Case Record Form (CRF)(d) Review of Data Management reports