FMD K&L provides expertise that can help you understand the challenges and complexities of global regulation and develop strategies to minimize risks and maximize benefits.
FMD K&L’s broad medical affairs expertise enables you to effectively manage your internal and external stakeholder engagement needs to bring clarity of direction to your brand goals Medical affairs is a multi-faceted functional area with activities spread across the key verticals of regulatory affairs, pharmacovigilance, post-marketing studies, and the sales and marketing of a brand. […]
FMD K&L applies a wide variety of operations expertise to meet the challenges that occur during every clinical development program.
FMD K&L biostatisticians provide a keen understanding of every aspect of clinical development programs Regardless of where your product may be in the process of development and regulatory approval, we offer the biostatistical experience and solutions required to help bring your product to market. With an efficient organizational structure designed to promote high-quality standards, we […]
FMD K&L supports end-to-end clinical data management activities at every stage, from development of electronic case report forms (eCRFs) through database lock Our CDM team is comprised of highly experienced data managers and developers who understand the requirements of sponsors, study sites, and statisticians. Excellent planning and proven SOPs enable us to provide high-quality data […]
FMD K&L’s statistical programming team provides excellent SAS programming services to the pharmaceutical and biopharmaceutical industries, including: Development of study data tabulation model (SDTM) datasets Development of analysis datasets (ADaM) Development of standard exchange of non-clinical data (SEND) datasets Creation of tables, listings, and figures (TLF), in-text tables & appendices Support of clinical study report […]
Safety issues are lurking everywhere; an unexpected adverse event or a change in regulatory reporting requirements could increase your exposure to risk.
FMD K&L’s toxicology team consists of researchers and toxicologists with long industry experience in preparing assessment reports concerning the safety of cosmetics, consumer products, and chemicals.
Medical writing plays a crucial role in drug development. Regulatory agencies demand accurate, error-free documentation and reporting.
In order to meet increasing standards of quality, risk obligations and compliance, organizations today face immense pressure to keep up with regulatory standards and audit expectations. FMD K&L recognizes the risk of business disruptions and unnecessary overhead resulting from inadequate audit preparation or non-compliance. Our quality, risk and compliance services are designed to remain minimally […]
FMD K&L consultants can help you develop an end-to-end approach to global product development that integrates clinical and commercial considerations. FMD K&L consultants provide expertise covering business strategies as well as clinical, regulatory, operations, technology, and safety considerations. Our diverse team of consultants can assist you in the development of pharmaceuticals, biologics, medical devices, combination […]
All FMD K&L services are available individually or as part of an end-to-end solution. FMD K&L services can help you achieve optimum results from your product development program and meet your scientific and marketing objectives.