30 years ago, we launched more than a pharmacovigilance service. We launched a lifelong commitment to ensuring patient safety across the world. Today we look back at pride and acknowledge the overwhelming support that we have received from our partners.
The COVID-19 pandemic knocked a lot of traditional practices that existed in clinical trials, with the emergence of practices like virtual trials. Pharmacovigilance regulations have been instrumental in ensuring the safety of patients as well as for participants in trials.
The Pharmacovigilance market is expected to reach 12billion$ according to a recent analysis by Emergent Research, indicative of the immense growth expected in this sector. Pharmacovigilance has evolved as a sharp-eyed mechanism that has a watchful eye on the safety of drugs that enter the market.
Leveraging 30+ Years of Pharmacovigilance Services
Patient safety is a critical aspect of healthcare, making it a vital component in core processes for Life Sciences companies. Hence, drug safety departments are increasingly focusing on core activities, to contribute their insights throughout the product lifecycle to ensure better risk management and effective market interventions.
In addition, there is pressure to achieve greater efficiency in the face of growing regulatory and compliance expectations. This had made it crucial for Life Sciences organizations to leverage technology to automate processes, use data to drive insights, and hence, improve efficiencies while supporting the safety profile of their drugs.
Major Contender in Everest Group’s Pharmacovigilance and Complaint Management Operations – Services PEAK Matrix® Assessment 2021
Customer Testimonials of our Pharmacovigilance Systems
1) QPPV office
The QPPV office of Navitas Life Sciences takes care of all QPPV activities as defined in legislation. QPPV services are offered since 2016 as part of the end-to-end PV services of Navitas Life Sciences.
Our clients are mostly located outside of the European Union but are providing pharmaceutical products within the EU. We leverage the expertise and experience of our in-house team, with more than 8 years of experience, to support these companies. Our clients appreciate our inspection readiness initiative; we prepare ourselves and our clients for potential inspections by authorities and audits. Our clients trust in our 24/7 availability to serve as a point of contact for competent authorities. Our network of local QPPVs, including the UK, completes our efforts for the EU QPPV services.
“Prompt services, Friendly and Approachable”
10 on 10 rating
2) Risk Management Plans (RMPs)
Risk Management Plans include information on a medicine's safety profile, how its risks will be prevented or minimized in patients, plans for studies, and other activities to gain more knowledge about the safety and efficacy of the medicine and measuring the effectiveness of risk-minimization measures.
The team of experienced medical writers at Navitas Life Sciences provides a full set of activities which includes scheduling, planning, development, approval, and distribution of RMPs.
a) A mid-size North American pharmaceutical and biotechnology company, specializing in the treatment of severe life-threatening diseases, was preparing for approval of its medicinal product in The United States and Europe.
Navitas Life Science’s RMP team helped the North American pharmaceutical and biotechnology company develop their Risk management Plan and submit to the concerned Health Authority for approval. Additional risk minimization measures were included with the flexibility to handle potential events that could impact a larger population worldwide. The entire process was audit-ready and engineered with traceability in place.
b) A mid-sized Indian Pharmaceutical company required support for risk management and for submitting approvals to multiple Health Authorities world-wide.
Navitas Life Sciences provided medical expertise to compile Risk Management Plans that helped continually manage and assess the situation to mitigate risks that are pivotal for optimizing resources while adhering to all compliance measures.
3) Clinical Pharmacovigilance
A mid-size North American pharmaceutical company specializing in the treatment of rare and life-threatening diseases, was preparing for its first New Drug Application (NDA) in The United States and marketing authorization in Europe.
Navitas Clinical PV team helped them to harmonize inconsistent processes and design unified global pharmacovigilance operating model, to ensure smooth migration of all collected PV data into one global safety database.
"Navitas is always willing to meet our needs. It is a true collaboration between Navitas and us. It has been a very good partnership. There is clear communication. Navitas team always provides prompt updates. We are extremely happy with Navitas and their performance.”
4) MICC (Medical Information Call Centre) Services
A mid-size European pharmaceutical company involved in the development of Natural Health products were facing issues with existing MICC service provider in the USA region with regards to data integrity, call quality, and under reporting of the calls.
Navitas MICC team helped them to harmonize inconsistent processes and design a unified global MICC operating model in Bogota, Colombia, to ensure smooth handling, scribing, and recording of calls through a designated cloud platform and all-in-one interactive web interface to report and track Product Quality Complaints (PQCs), Medical Inquiries (MIs) and Adverse events (AE).
“Fast response in case of any questions,
Very competent and motivated team
Effective database with the possibility to work online”
10 on 10 rating
5) ICSR Services
A Canadian generic drug and therapeutic company was facing constraints in managing cases in-house. They had limited resource to process a large backlog and maintain compliance, and hence required our expertise. We received a project that involved dozens of prescription products with end-to-end (E2E) processing of all cases (new and backlog) including study, spontaneous and literature cases.
Within a span of 4 months, we were able to successfully process dozens of backlog cases whilst also picking up the regular cases, with an average volume of 600-1000 case per month.
We received appreciation for the great work and were subsequently awarded additional product portfolios and safety activities (Aggregate Reports, Signal Management).
6) ICSR Services - Success story 2
A mid-sized generic company headquartered in India felt that efforts, time, and costs were high due to data basing of additional cases and hence wanted a suitable partner to explore opportunities to optimize and gain efficiencies. There was also a need to build an IQC process that reflected industry best practices for optimal quality and compliance.
Our efforts resulted in a 30% reduction in operational costs by non-reporting of non-company cases for the client and building a robust Independent quality check process based on industry best practices.
Overwhelming Customer Appreciation and Reviews of our work
Navitas Life Sciences has been at the forefront of new developments in Pharmacovigilance for more than 30 years. Our Consulting Team has defined and implemented PV processes, governance practices and even organizations in more than 300 Life Sciences companies.