Safeguarding Lives, Ensuring Drug Safety
With a commitment to patient safety and regulatory compliance, we provide comprehensive drug safety solutions to pharmaceutical companies, healthcare professionals, and patients.
Our expert team leverages advanced technologies and global standards to monitor, assess, and mitigate risks associated with medicinal products. Together, we ensure safer healthcare for everyone.
We would love to hear from you; Why not book an appointment.
Our Values
We are committed to maintaining ethical standards in all areas of our operations. Our goal is to work closely with clients, healthcare providers and regulators, leveraging technology to deliver exceptional pharmacovigilance solutions while ensuring the safety and efficacy of medicinal products through rigorous pharmacovigilance practises.
Healthy Lifestyle
Stemax consult is a member of British Society of Lifestyle medicine helping to improve health and wellbeing of Individuals.
Lifestyle medicine is an evidence based clinical care that supports behavior change through person- centered techniques to improve mental wellbeing, social connections, healthy eating, physical activity, sleep and minimalization of harmful substances and behaviors.
We tend to address this issue to the wellbeing and health of the society, thereby giving hope to the state of their health been properly managed.
Our Services
Adverse Event Reporting and Management:
Streamlined reporting systems for adverse drug reactions.
End-to-end case management ensuring regulatory compliance.
Real-time monitoring and analysis to identify safety signals.
Regulatory Compliance Support:
Adherence to global pharmacovigilance regulations
Customized solutions for local and international markets.
Audit preparation and inspection readiness.
Literature Monitoring and Medical Writing:
Comprehensive scientific literature reviews for safety data.
Preparation of high-quality pharmacovigilance documents.
Expertise in preparing narratives, aggregate reports, and regulatory submissions.
Risk Management Services:
Development and implementation of Risk Management Plans (RMPs). Periodic Safety Update Reports (PSURs) and Risk-Benefit Evaluation Reports. Proactive safety measures for high-risk medications.
Signal Detection and Assessment:
Advanced data mining and statistical analysis. Early detection of potential safety issues. Collaborative safety review with healthcare authorities.
Why Choose Us?
With decades of collective experience in drug safety and regulatory affairs, our team of skilled pharmacovigilance experts possesses deep knowledge across various global regulatory environments.
Leveraging cutting-edge tools for data management and safety analysis, we are dedicated to patient-centric approach, prioritising the deduction of risks and the enhancement of patient care.
Training
Interested in Pharmacovigilance training? We offer a range of comprehensive programs tailored for both individuals seeking to enter pharmaceutical roles and those already working in pharmacovigilance. Our training options include:
One-on-one sessions, small group training, introductory pharmacovigilance for non scientists, drug safety and risk management, overview for senior management, in-house training, risk management training, & SOP training.
Let us help you strengthen your expertise and advance your career in pharmacovigilance.
Inspection Readiness Services in Pharmacovigilance
Our customised programs are designed to help pharmaceutical companies prepare for regulatory inspections while ensuring compliance with pharmacovigilance regulations. Our services include:
Inspection readiness training, preparation of pharmacovigilance systems summaries, internal audits, mock interviews, & qualified person for pharmacovigilance (QPPV) representation.
Let us assist you in achieving full compliance and ensuring comprehensive preparation for inspections.