Safety issues lurk everywhere; an unexpected adverse event or change in regulatory reporting requirements could increase your exposure to risk
FMD K&L specializes in product safety and risk management for pharmaceuticals, biopharmaceuticals, medical devices, and cosmetics.
Product safety services
To limit your exposure to risk, we provide a team of highly qualified, experienced physicians and healthcare professionals focused on delivering expert pharmacovigilance, cosmetovigilance, and materiovigilance services.
Our team offers end-to-end safety solutions covering the entire product lifecycle from development to post-marketing surveillance. We intelligently apply the latest technology innovations to extract optimum value from acquired safety data.
We address evolving issues related to products and processes evaluating their safety. Our global delivery centers leverage the expertise of safety professionals familiar with requirements throughout the world to assist in developing your product wherever you choose to operate.
Whatever your requirement for product safety, FMD K&L is a partner you can trust to deliver exceptional results and peace of mind.
Risk management services
Preparation of medical product safety documentation supporting product registration can be a challenging multidisciplinary process. Our safety team offers the full range of expertise required to accurately assess risks and develop effective mitigation strategies for pharmaceuticals, biopharmaceuticals, consumer health products, medical devices, and OTC products.
We support applicants and market authorization holders (MAHs) to prepare, collect, and assess the data required to comply with regulatory standards. We then assist in developing risk management plans (RMPs) and risk evaluation and mitigation strategies (REMS) that are fully compliant with current Good Pharmacovigilance Practice (GVP) requirements.
- Detailed pharmacovigilance plans
- Risk management strategies
- Benefit/risk related services
- Document writing
Our risk management experience
- Our healthcare professionals, including pharmacists, PhDs, post-doctorates and MDs, have at least 10 years’ experience
- Our team leads have at least 5 years’ experience
- Our practice associates have at least 3–4 years’ experience
- Analyzing & writing safety information reviews & revisions
- Overseeing & tracking medical monitoring activities
- Evaluating risk/benefit
- Writing all sections of medical assessments
- Developing & writing full safety profiles
- Writing risk-related position papers from various databases
- Developing & writing integrated summaries of safety (ISS)
- Preparing template-based contents
- Performing thorough literature searches & assessments of epidemiology
- Identifying important risks & missing information
- Reviewing & determining adequate measures for routine & additional risk minimization
- Generating submission-ready RMPs
- Checking process assessments to document effectiveness