Keys to Advancing Your Biotech Go-to-Market Plan

For nearly 10 years, a growing biotech company worked to develop a nitric oxide and delivery device for babies in the newborn intensive care units (NICU). The organization also needed to file the appropriate documents for Food and Drug Administration (FDA) approval to bring this combination drug and device to market.

Confronted with the myriad of complexities of the 510K FDA filing process, this company also had to address the challenges of an unreliable internal infrastructure to advance the development of the product.

Essential Steps to Consider

Engage the right partner: Identify and engage a trusted strategic partner who brings a multi-dimensional perspective – strategic and tactical to your go-to-market plan. Your strategic partner should be able to provide insightful and comprehensive regulatory guidance for meeting the stringent FDA requirements for drug and device combination products.

Identify and assess: Critical to an effective and compliant manufacturing plan is developing and implementing current good manufacturing practice (cGMP) gaps in infrastructure.

For growing biotech companies, an analysis may reveal the need for:

• FDA filing process assistance: Life cycle FDA regulatory support from experienced, FDA veterans through the FDA regulatory communication process
• Experienced research and development (R&D) project management: Supplemental and scalable infrastructural support in project management with specific expertise in growing life-sciences companies
• Quality management: Expert, ready-to-contribute manufacturing personnel to create and implement a quality control system in compliance with cGMP regulations
• Strategic advisory support: Step-by-step plan for gaining FDA approval and advancing their drug/device combination to market
• Clinical oversight management structure: The basis for a successful internal infrastructure within the organization
• Comprehensive R&D expertise: Multidimensional perspectives from seasoned experts in regulatory affairs, clinical research operations, project management, and quality management experts ensured advancement through the entire 510K FDA filing process
• Seamless implementation: Access to a scalable, flexible team of consultants with experience in implementing quality manufacturing experts; chemistry, manufacturing, and control (CMC); technical writers; and FDA communication practitioners to complete the new drug application (NDA) filing

What is Your Return on Investment?

Accelerate Time-to-FDA Approval and Market Commercialization

Eliminate the usual back and forth with the FDA and advance through a complicated filing process at a much quicker rate.

A growing biotech company obtained FDA approval for their combination drug and device within three years. Five months after approval, this company was able to launch its combination drug and device to the market.

Save Time and Money

Reallocate internal resources and save valuable time and resources through an accelerated timeline.

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