FMD K&L applies its expertise in medical science, operations, regulatory affairs, and technology to assist clients with the high-level decisions required to formulate an effective strategy.
FMD K&L’s strategic consulting team is composed of senior experts with extensive experience in global product development. Our team develops strategies that are specific for the product and indication, while having the flexibility to support diverse regions of registration. We develop strategies that are always based on the most current market intelligence and on realistic assessments of data and regulatory requirements.
The FMD K&L consulting team creates strategies utilizing the most efficient registration pathways that offer a higher probability of regulatory approval and that optimize entry into global markets. FMD K&L consultants conduct gap analyses to carefully evaluate programs for potential risks, suggest effective corrective actions, and assess a product’s chances for first-pass approval.
- Expertise in small molecules, biologics, vaccines, medical devices, combination products, consumer health products, and cosmetics
- Strong relationships with regulatory authorities in the US, EU, and ROW
- Experience with hundreds of successful submissions and approvals throughout the world
- Large network of key opinion leaders in a vast array of indications and geographic regions
- Market assessment, research, and intelligence
- Competitive analysis
- Indication prioritization
- Claims prioritization and substantiation
- Clinical safety plans
- Product value proposition
- Pricing and reimbursement
- Flexible Go-to-Market models that adapt based on clinical data