In the business of working with emerging to mid-sized Biotech and Pharma Companies

Corevigilance was started due to the need for a focused partner who p‚Äčuts the client first.  We represent the Sponsor when the sponsor doesn't have the experienced staff on site to monitor their Clinical, Regulatory, Drug Safety/PV and Quality programs.  

Our team provides personalized consulting services to lead your projects to completion with well experienced professionals.


What makes us different?

  • Consultants who are experienced and well vetted.
  • We bring our best self each day and that is why we only choose the best fit for your needs. 
  • Our team of consultants have over 30 years of experience and we only staff with consultants with experience in their specified area of service.    
  • Our senior team members have management backgrounds.  They are former senior level employees from large pharmaceutical companies, biotech and CRO's. They understand what client's needs are and will guide you in the oversight of your day-to-day needs. 

WHY CHOOSE US?

No red tape, no large corporate waiting times and we surpass expectations at every turn! 

 We are different, We Care, We partner with you to meet your goals.


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An example of some of our areas of expertise: 

  • Pharmacovigilance/Drug Safety in Clinical and Post Marketing Safety operations
  • Migration of ICSR's from database to database/vendor to vendor
  • Vendor Selection/RFP's
  • PV Vendor oversight
  • Quality and Compliance
  • SOP Development
  • Inspection readiness
  • Project Plans: SMPs, Communication plans, reconciliation plans, etc.
  • Gap analysis

Feel free to contact us to develop a plan that fits your needs.

[email protected]







CEO and President, Maria Licwinko, is passionate about Pharmacovigilance and Quality.  Maria started her career  as an Oncology nurse at Thomas Jefferson University Hospital in Philadelphia.  She worked within the Cancer center with world renowned physicians delivering state of the art treatments to patients.  It is there that she became passionate about research and how it could improve patient outcomes. Fast forward to 2001 and she moved to the corporate world in the pharma industry working in drug safety/pharmacovigilance.  Over the years she grew her career working in large pharmaceutical companies where she learned best practices and within large CRO's working with a multitude of different biotech and pharma clients eventually moving to a leadership role overseeing teams in the US, India and Mexico.   

Maria founded Corevigilance out of a need for close collaboration and detailed oversight for small biotech and pharma who did not have Pharmacovigilance expertise on board.  Maria's experience in project management, regulatory, medical information, PV quality and compliance, marketing, finance and auditing has helped numerous clients navigatge their PV/ drug safety departments, ensuring they are inspection ready and have a sound foundation.   

Maria is passionate about delivering quality work  and having the right people on board who can ensure your company is inspection ready and has the best team.   Her consultants are all experienced in their areas with more than 15 years each in their areas of expertise!