PHARMACOVIGILANCE & DRUG SAFETY
Radikan Pharm-Med Ltd. provides specialised pharmacovigilance and drug safety services, supporting organisations with product safety, risk management, clinical trial safety, regulatory requirements, and benefit–risk assessment.
Comprehensive pharmacovigilance experience covering case management, safety surveillance, signal management, risk management and communication, and benefit-risk assessment.
Helping pharma and biotech companies navigate complex drug safety requirements during clinical development and after approval through applied knowledge and experience of Global PV regulations.
Supporting high standards of patient safety, quality, and responsible pharmacovigilance practices.
Providing practical, reliable, and evidence-based pharmacovigilance guidance to pharma and biotech companies. Our scalable model also provides access to experienced PV physicians and safety scientists, working under senior medical oversight to meet evolving project and organisational needs.
ABOUT RADIKAN PHARM-MED
Radikan Pharm-Med Ltd. provides specialist pharmacovigilance physician consultancy services to pharmaceutical and biotechnology companies across the full product lifecycle—from First-in-Human studies and clinical development through regulatory submission, product launch and post-marketing use. Experience includes consulting on setting up and overseeing compassionate use programs, post-marketing registries and safety studies.
Our services combine strategic safety leadership with hands-on medical expertise in individual case assessment, safety surveillance, signal management, risk management, benefit–risk evaluation, and safety governance, compliance, and communication.
Extensive experience in authoring and reviewing safety documents, including PSUR, DSUR, RMP, IB, DCSI, ICF, CSR, CCDS, aRMM tools, Prescribing Information, Regulatory responses, and Submission documents.
Experience spans investigational and marketed products across oncology, immunology, infectious diseases, diabetes, cardiovascular medicine, and neurology.
We can also provide practical, reliable, and evidence-based pharmacovigilance guidance to pharma and biotech companies through a scalable model that provides access to experienced PV physicians and safety scientists, working under senior medical oversight to meet evolving project and organisational needs.
OUR SERVICES
OUR WORKING PROCESS
We begin by understanding your organisation, objectives, challenges, and specific pharmacovigilance and drug safety requirements
We assess your requirements and develop a practical, evidence-based approach tailored to your project and regulatory needs.
We provide ongoing professional guidance, clear documentation, and reliable consultancy support to help you achieve your goals.
