Client Development Stage

Stage-appropriate Strategies to Support Growth

Preclinical

Orphan Drug Consulting understand the shift in mindset required for a company to transition from a preclinical to clinical company. For many in the rare disease and innovator space, this change from a research-focused company into a clinical organization is further complicated by small patient sample sizes and complex product requirements. Orphan Drug Consulting support preclinical companies by:

Providing organizational and growth strategy to ensure key functions are established, while remaining flexible to adapt to future requirements.
Establishing outsourced manufacturing and clinical supply networks along with demand forecasting to ensure your product gets to trial sites.
Designing quality systems (QMS) and business processes that are scalable and appropriate for a company’s development stage to support future needs.

Clinical

The progression through clinical trials towards commercialization can bring with it unique challenges that impact the wider organization. Companies looking to bring their product to the market are constantly faced with multiple launch and operating models, making it difficult to determine the most appropriate strategy for their business. Orphan Drug Consulting support clinical companies by:

Determining the holistic commercial strategy and organizational/operating model requirements across multiple functions and focus areas, along with country/region-specific requirements to provide integrated product launch management.
Expanded/early access programme (EAP) strategy and implementation.
Build out of quality and business systems, including license/registration acquisitions, to support growing organizational requirements.

Commercial

Successfully marketing a product is an important milestone in a company’s development lifecycle, however expanding this product to additional markets brings with it unique complexities and specific requirements that must be considered, while also maintaining responsibilities within the marketed region. Orphan Drug Consulting support commercial companies by:

Maintenance of existing infrastructure and ongoing logistical support.
Fulfilment of interim management positions post-launch to ensure seamless transition to newly established organizational structure.
Leading product launch into additional markets and regions.
Supporting ongoing vendor management.

Meet the Team

We are a team of industry-leading subject matter experts (SME’s) and professionals who provide consulting services to innovative pharmaceutical and biotech companies, meeting their needs and launching products to global markets.