Zero to QMS: How a One-Person Quality Team Used Consultants to Scale a QMS and Gain Full FDA Compliance
What began as a focused SOP project evolved into an 18-month transformation, demonstrating how the right consulting partnership can help virtual pharma companies build sophisticated quality systems.
The pharmaceutical landscape is evolving. While traditional pharma companies operate with sprawling infrastructure — manufacturing plants, labs, and warehouses — virtual pharma companies take a leaner approach. These organizations maintain minimal physical presence, orchestrating networks of contract manufacturers, labs, and distributors to bring medicines to market.
This virtual model drives agility and efficiency but demands sophisticated quality oversight. Companies must meet the same FDA standards as traditional manufacturers while coordinating quality systems across a web of external partners.
This case study follows a virtual pharmaceutical startup that acquired rights to manufacture a life-saving drug, then faced an urgent challenge: building comprehensive quality systems from scratch without disrupting critical production and distribution.
What began as a request for basic SOPs evolved into an 18-month partnership. Working with The FDA Group, the company built a complete quality management system, qualified suppliers, audited distribution centers, and established regulatory compliance — from CMO oversight to complaint handling and FDA reporting.
If you need full-time or part-time contracted RA/QA/Clinical resources, don't hesitate to contact us. Given the regulatory challenges and budget constraints many teams are experiencing, and the flight of some of the industry’s best talent into the consulting pool, these flexible, expert resources have been in high demand.
The problem
The company needed to rapidly establish quality systems after acquiring rights to manufacture a critical life-saving drug. With minimal internal staff and primarily outsourced operations, the company faced the complex challenge of building compliant systems while maintaining ongoing production and distribution of its therapeutic product.
The company's newly hired Director of Quality, who had only been with the organization for a few months, initially reached out to The FDA Group seeking assistance with a gap analysis and high-priority SOPs. The Director recognized that the existing QMS was inadequate for the company’s growing operations. As a virtual organization, the firm faced significant resource constraints, with Quality operations initially consisting of just one person — the Director himself.
The organization faced multiple interconnected challenges:
Managing a life-saving drug product with strict timing requirements for patient administration
Operating virtually with minimal internal staff
Overseeing a foreign CMO
Establishing and managing relationships with major healthcare distributors
Ensuring FDA compliance as a newly formed organization
Meeting various regulatory reporting requirements
Managing product stability and lifecycle considerations
The FDA Group’s approach and solution
What began as a focused SOP development project evolved into a comprehensive Quality partnership spanning nearly two years. The FDA Group established bi-weekly meetings with the client from the outset, ensuring consistent communication and rapid response to emerging needs.
The engagement unfolded in several phases:
Initial phase: high-priority SOP development
The first QA consultant was brought in to conduct a gap analysis and develop critical SOPs. However, it quickly became apparent that the scope of work needed to be broader. The Director, being new to the company and responsible for high-level operations, realized he couldn't manage the full QMS development independently as initially planned.
QMS development
The FDA Group deployed a second Quality consultant specializing in building quality systems from scratch. This consultant worked with the client for approximately 18 months, eventually extending to nearly two years, providing two crucial services:
Development of a complete, right-sized QMS appropriate for a virtual pharmaceutical company
Strategic advisory support to the Director of Quality, serving as a valuable sounding board for Quality decisions and strategy
The consultant took particular care in right-sizing the QMS, recognizing that while large corporations might need extensive systems, this virtual organization required a more focused approach. They provided options and ideas while allowing the Director to make final decisions appropriate for the organization.
Distribution center qualification
As the QMS development progressed, it became clear that the company needed to establish proper oversight of its distribution partners.
The FDA Group provided a specialist who conducted 4-5 audits of different distribution centers. Importantly, the consultants helped optimize this process, advising that not every distribution site needed to be audited. This ultimately saved the company significant time and resources compared to the initial plan for 10-15 audits.
Additional specialized support
Throughout the engagement, The FDA Group provided several specialized consultants to address emerging needs beyond core QMS development:
CMO Oversight and Expansion: The company’s primary CMO required significant oversight and support, leading The FDA Group to provide supplementary GMP audit support for this critical manufacturing relationship. As manufacturing capacity needs grew, the company sought to diversify its manufacturing capabilities. The FDA Group provided a consultant based in Italy to conduct supplier qualification activities for a potential European CMO, supporting the team’s strategy for geographical expansion and increased production capacity.
Regulatory Reporting and Compliance: A focused consulting engagement helped establish the client's CARES Act reporting processes. This project included guidance on the filing process and data accuracy requirements for submissions. In parallel, consultants helped develop robust systems for complaint handling and reporting, creating templates and processes for collecting complaint data and providing required reports to the FDA. This included establishing statistical tracking mechanisms and formal procedures for managing the complaint reporting process.
Product Lifecycle Management: When faced with decisions about aging product inventory and non-production batches, the company engaged The FDA Group's regulatory expertise to assess options and determine appropriate handling procedures. A consultant provided specific regulatory guidance for managing these materials within compliance requirements.
These additional support activities typically emerged through regular meetings, where the client team identified new needs, and The FDA Group would source appropriate expertise. This pattern of engagement demonstrated the evolution of the relationship from a targeted QMS development project to a comprehensive Quality partnership, with the company consistently turning to The FDA Group as its first resource for emerging Quality and regulatory needs.
Results
The partnership delivered several key outcomes:
Established a functional QMS appropriate for a virtual operating model
Created confidence in FDA compliance position
Developed robust templates and procedures for regulatory reporting
Provided framework for training incoming Quality staff
Gained effective oversight of the distribution network through targeted audits
Optimized audit strategy, reducing planned distribution center audits from 10-15 to 4-5 critical sites
Established efficient processes for complaint handling and CARES Act reporting
Created sustainable frameworks for CMO oversight
The engagement demonstrated the value of having experienced Quality professionals available during a critical growth phase. The Director of Quality, initially operating as a "Quality department of one," found particular value in having a trusted sounding board for strategic decisions.
As the company built its internal Quality team, it gradually reduced its reliance on consulting support. This transition was natural and strategic, having established the fundamental quality systems and processes needed for its operations. The Director of Quality repeatedly appreciated the partnership's role in establishing a solid foundation for the growing Quality organization.
The engagement demonstrated The FDA Group's ability to serve as a comprehensive Quality partner, adapting to evolving client needs while providing strategic guidance to help a startup organization build appropriate quality systems efficiently.
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We can fulfill contracted and direct hire resource placement needs in a variety of quality roles and functions, including, but not limited to:
Global/Regional Director
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Do you have projects that require short-term, intensive regulatory or quality support but do not justify long-term hires?
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Are there critical projects or audits approaching that your current team may not have the capacity to handle?
Are there key personnel in your RA/QA team who are on extended leave or have recently left the organization?
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Do you need to hire for a full-time role but are struggling to capture the scope of the position?
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Who is The FDA Group?
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