A Rare Partner for
Rare Disease
Treat­ments

Commercial­ization
services that help orphan
drugs reach their full potential

A Rare Partner in Rare Diseases

Commercialization services that help orphan drugs reach their potential

Helping orphan drugs navigate the U.S. market

RDT is a full-service partner for manufacturers of:

RDT is…

Agile

Agile leadership adapts to the needs of each rare disease community

Experienced

Experts in targeted education using a specialized salesforce

Visionary

Rare disease clinical trial adaptations that are future-focused

Knowledgeable

Relationships with global thought leaders and leading-edge academics

Impactful

Exclusively focused on orphan drugs for unmet medical needs

Efficient

Lean, integrated processes adapt to optimize results

Rare Disease
Sales and
Marketing Support

Specialized expertise
for orphan drugs

Decades of experience in rare disease allows us to partner with influential thought leaders. One of the most challenging parts of commercializing orphan drugs is getting them to the patients who need them.

Rare Disease Sales and Marketing Support

Specialized expertise for orphan drugs

Decades of experience in rare disease allows us to partner with influential thought leaders. One of the most challenging parts of commercializing orphan drugs is getting them to the patients who need them.

Our orphan drug commercialization process combines
precision and expertise

Identifying patients and their needs and behaviors

Successfully securing contracts with large healthcare systems

Finding healthcare specialists who are treating patients with rare diseases

Creating compelling promotional and educational materials that comply with FDA and federal regulations and guidances

Identifying patients and their needs and behaviors

Finding healthcare specialists who are treating patients with rare diseases

Successfully securing contracts with large healthcare systems

Creating compelling promotional and educational materials that comply with FDA regulations and guidance

Gaining favorable access to help ensure fulfillment

Orphan Drug Regulatory Support

Supporting orphan drug submissions to the FDA for the treatment of rare diseases

Expert knowledge and experience in navigating the regulatory process for an Investigational New Drug (IND) application, a Biologics License Application (BLA), or a New Drug Application (NDA) for an orphan drug with the U.S. Food and Drug Administration (FDA).

Our world-class regulatory team is skilled in navigating all of the steps from pre-approval, through launch, to post-approval maintenance submissions.

Whether it’s leading meetings with the FDA as a U.S. Agent or preparing applications, Orphan Drug Designation requests, briefing documents, supplements, amendments or other submissions, our proven track record of getting orphan drugs to market speaks for itself.

Orphan Drug Regulatory Support

Supporting orphan drug submissions to the FDA for the treatment of rare disease

Expert knowledge and experience navigating the regulatory process for an Investigational New Drug (IND) application, a Biologic License Application (BLA), or a New Drug Application (NDA) for an orphan drug with the US Food and Drug Administration (FDA) is complicated.

Our world-class Regulatory team is equipped to navigate all of the steps through launch.

Whether it’s preparing briefing documents,  submissions, leading meetings with the FDA as a US Agent, or securing Orphan Drug Designations, our proven track record of getting orphan drugs to market speaks for itself.

Critical roles at RDT for the development & approval of orphan drugs

Regulatory

Clinical

Clinical

Medical

Rare Disease Experts

Quality Assurance

Quality Assurance

Pharmacovigilance

Medical Affairs
for Rare Diseases

Medical Affairs
for Rare
Diseases

Medical strategies designed to
engage HCPs to optimize patient care

Clinical Trial Consulting for Rare Diseases

Study design support and optimization for orphan drugs

RDT’s Medical Affairs team works with partners to provide medical strategies for product development, approval, and rare disease state education. Orphan drugs are unique and require a targeted approach. Critical roles include:

Scientific & medical communication

Medical writing

KOL engagement

HCP education

Clinical trial consulting

Orphan drug market analysis