Pharmacovigilance & Medical Device Product Strategy Throughout the Life Cycle Management

Symogen has designed a new model for supporting and providing strategy for the needs of the scientific functions within pharmaceutical and medical device companies throughout the life cycle management of their products. Our teams of experienced medical and scientific experts are helping our clients become more strategic and effective in achieving their goals.

Who We Are

Our teams consist of experienced medical and scientific experts who have the knowledge needed to solve the industry's most complex problems and the capability to execute and implement the processes to bring efficiency

Symogen has Supported Small, Medium and Large Pharmaceutical and Medical Device Companies

5+ launches supported by our project teams over the past two years

Over 50 different therapeutic areas supported by our physicians and scientific experts


How Symogen Supports Clients

Listen & Understand. Strategize & Advise. Implement & Execute.

Our teams of expert physicians and scientists focus on understanding the issues, goals and needs of our clients. We then put several strategies in place and discuss with our clients to customize our approach to our client's specific needs and act as an extension of their team. All the projects are approached in collaboration with our clients to support and build new capabilities and processes thus bringing efficiency and smooth implementation and execution of the processes.

  • Product Launch Readiness Support
  • Interim Medical Executive Support
  • Pharmacovigilance (PV) and Medical Program Management Strategy
  • Product Lifecycle Management and Evidence Generation Strategies and end to end support for routine and ad-hoc tasks
  • Pharmacovigilance Audits and Inspection Management Strategies and Support
  • Pharmacovigilance System Improvement and Remediation Strategies and Support
  • EU MDR Strategy Planning and Implementation Support

Brief Insight into some of the projects that
Symogen has supported clients

Large European MNC selected Symogen to strategise signal detection process including implementation of the signal detection tool. Symogen provided different signal detection and management methodologies and the associated processes for each methodology for both qualitative and quantitative methods. Symogen then proposed several signal management tools that was fit for purpose to the selected signal methodology. Additionally, Symogen also supported and prepared the SOPs for the same.
Large MNC selected Symogen to provide strategy for the transfer of key product portfolios and smooth integration from Clients USA Office to its HQs in Europe. Symogen worked with the clients team and provided strategy to move the portfolios and smooth transition to bring in efficiency in the process and tasks. Additionally, the key products were then outsourced to Symogen for end to end pharmacovigilance services.
Large European MNC required strategy and support with their Line Listing retrieval process and implementation for pharmacovigilance regulatory reports such as PBRERs, ACOs, DSURs etc. Symogen put in a strategy to streamline the Line listings and the parameters and selection criteria’s to pull out the correct listings required for various regulatory reports. This not only brought fit for purpose listings but also efficiency.
Symogen was selected to review the auto labelling process which was not done correctly by another vendor that resulted in incorrect safety assessments during case processing and medical review of cases. Symogen reviewed the current auto-labelling process and then proposed an efficient process to correct the auto-labelling of several important products in a phased manner for implementation.
Detailed strategy and process was put in place to manage and support PV Inspections from major authorities. This involved remediation plans and strategies, preparation of War Room” with relevant staff, organisation charts, company staff Q&A preparation and support of the actual inspection.
Large Indian MNC selected Symogen for their audits and Inspections projects. Symogen team strategized the CAPA process. Following the clients inspections, Symogen then supported the CAPA implementation.
Large US MNC selected Symogen to strategize, support and prepare over 30+ CCSI & LCOV for their products from scratch. Symogen team prepared the strategy and implemented the process. Additionally, Symogen’s team of physicians and medical writers and scientists supported in the preparation of the CCSIs and LCOV for over 30 products within the set timelines.
Large European MNC selected Symogen to provide strategy for product approval in Japan. Symogen’s extensive safety experience with Japanese regulations helped the client in obtaining approval of their important product in Japan.
Mid sized MNC selected Symogen to provide strategy for product approval in USA for 3 of their products. Following strategic advice and support from Symogen, the clients received approval for the 3 products.
Symogen was selected to provide strategy for SakiGake and FDA AdCom preparation of answers to several key questions including Important Identified and Potential Risks. Additionally, Symogen also prepared the Risk Management Plan and prepared a strategy for Additional Risk Minimisation Measures which helped in approval of the key oncology products and another orphan drug.
A British pharmaceutical company selected Symogen to support approval of a drug indicated for paediatric population. Symogen supported this task using Real World Evidence data from CPRD. Symogen prepared the protocol, which was approved by the regulators and then the protocol was also approved by the CPRD. Data from CPRD was then transferred to Symogen maintaining strict confidentiality for analysis and preparation of the report for approval of the drug.
Large US MNC selected Symogen to put in a strategy for preparation of Clinical Evaluation Reports as part of fulfilling EU MDR Regulations. Symogen experts prepared the strategy and implementation of the process that involved cross functional team members from several regions. Additionally, Symogen was awarded the contract to prepare multiple CERs.
Large US MNC selected Symogen to prepare the strategy for PMCF activities as part of EU MDR. Symogen was also selected to provide Survey of several of the client’s products as part of clinical follow-up of PMCF activities.

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With an impeccable track record of quality and highly ethical practices, Symogen serves global clients that include start-ups, mid-sized enterprises and fortune 100 companies.

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