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A leading Generics Company with R&D capability with several drugs in clinical development pipeline requested Symogen Limited to help set up and strategise Pharmacovigilance in Europe and globally. Symogen Limited has helped the company in advising on Global PV database set up including systems and processes, CTs safety support, prepare Safety management Plans for drugs in development, set up of and advise on Prescription Event Monitoring (PEM) Studies for drugs in India with KOLs; audit and inspections of all their affiliate offices globally; set up of PSUR processes and systems and authoring; developing and preparing CCDS from scratch and help prepare Safety Data Exchange Agreements (SDEAs).See All Services
A MNC requested Symogen Limited to help in the entire PV management and work for global NDA submission of novel Oncology product to FDA, EMA and PMDA. Symogen Limited managed the entire project including assessment, analysis of various data from several Phase II and III clinical trials, DSMB data review, assessment and responding to DSMB, reviewing and authoring of several important documents including Integrated Safety Summary (ISS); Clinical Study Reports; Patient narratives and safety narratives, DDPS etc. Symogen Limited also prepared from scratch the Risk Management Plans, EU SmPC, US PI and other safety documents for eCTD submissions globally. This project was completed by Symogen Limited in 12 months time and well before global submissions that enabled the sponsor company to submit MAA to all the three regulatory agencies FDA, EMA and PMDA before the actual date of submission.See All Services
A MNC requested Symogen Limited to help them with setting up and strategise a Good PSUR Practice process, as they had received several assessment reports from various regulatory agencies regarding the low quality standard of its PSUR which was one of the triggers for an inspection. Symogen Limited helped the company by spending over four weeks in understanding the current set up and then entirely changed the process and gave training in writing a PSUR including understanding the content and developing a new PSUR template as per EU regulations. Symogen Limited also helped the sponsor company to set up a pilot project for the PSURs and in strategising which PSUR should be done in house and which outsourced. With the implementation of this new process and setting up of the Good PSUR Practice, regulatory authorities have sent positive feedback and assessment reports to the sponsor.See All Services
A MNC requested Symogen Limited for urgent help to review and close over more than 7000 PT terms each of the Signals for their Transplant and Oncology portfolio group of drugs. This project included detailed analysis of the events and Issue Work Up of these signals identified through Quantitative Signal Detection and Management Tool and then authoring of several Safety Reports for the signals that were generated for submission to the Regulatory Authorities. This project helped the sponsors to get on top of the signals for these therapeutic areas and close all the signals.See All Services
A MNC requested Symogen Limited to help with an Urgent Analysis and Comprehensive report authoring of a Specific Urgent Safety Issue that had to be submitted to EMA as part of CHMP request. Symogen Limited executed the project by doing a detailed analysis of all the events involved for this specific issue, wrote the entire report consisting of more than 200 pages and also authored the Dear HCP letter for submission to the Regulatory Authority.See All Services
A MNC requested a comprehensive assessment of both the pre and post marketing activities in its European headquarters and UK and Irish affiliates, and also requested help and expert advice in the preparation of upcoming MHRA Inspection. Contacted Symogen Limited for under taking Mock Inspection, as PV experts for QPPV Inspection, Inspection for Global Central Operations and Affiliate Pharmacovigilance Inspection. The assessment was conducted over a three-week period by an experienced pharmacovigilance expert and QPPV. The experienced pharmacovigilance expert ensured that the assessment identified key gaps in pharmacovigilance systems, and that pragmatic and effective recommendations for improvements were made. The company received the assessment report very positively and implemented corrective actions before the inspection. For those corrective actions that required a longer implementation period, a plan of action was prepared which was acceptable to the regulatory inspectors. As a result of the assessment, pharmacovigilance personnel were well prepared for the subsequent inspection, which progressed smoothly with very few findingsSee All Services
A MNC requested Symogen Limited for help with their forthcoming MHRA Inspections in PV after receiving several critical findings in previous inspections from various competent authorities. Symogen Limited helped them by changing and implementing several processes and handled the inspections professionally which resulted in positive comments by the inspectors and less significant findings.See All Services
A MNC requested Symogen Limited for help with developing and preparing of several SDEAs for various products as part of the commitment following several inspections. Symogen Limited helped the company in preparing these legal documents interacting with pharmacovigilance department, legal department and various other license partners.See All Services
Professionals with an abundance of pharmacovigilance experience used to produce quality work in a timely fashion. Symogen values success of the team and is genereous in sharing their experience, knowledge and time.
Excellent knowledge in pharmacovigilance especially in Signal Detection and Risk Management. Approachable and executes work meticulously, accurately and on time.
Well-known for high-quality and compliant work among Japanese pharma companies. Managed large projects in various countries. Highly-experienced, energetic, straightforward, dedicated, honest, and down-to-earth professional team who can turnaround difficult situations in pharmacovigilance with ease.
Opportunity to face one of the Pharmacovigilance audit in India conducted by Symogen. It was very good experience for me and the experience shared provided a lot of in-depth understanding of Pharmacovigilance practices. A great person and team to work with and one can grasp a lot of technical information from Dr. Pippa
Excellent and deep knowledge on all aspects of Pharmacovigilance & Risk Management including safety evaluation, signal detection and regulations. Delivers high quality work on every project; extremely punctual, inventive, consistent and reliable. A great asset, great understanding in this field and implements projects to the highest quality.
Deep understanding of safety risk management; is a real asset to companies needing pharmacovigilance support.