A Rare Partner for
Rare Disease
Treatments
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:
- Phase 2/Phase 3 orphan drugs that are in need of clinical trial support
- Late-stage orphan drugs looking for regulatory support for FDA registration
- Approved orphan drugs requiring regulatory, quality assurance, pharmacovigilance, sales, and/or marketing support
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
Rare Disease Sales and Marketing Support
Specialized expertise for orphan drugs
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
Medical
Rare Disease Experts
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: