15 years in business has brought growth, trusted partnerships and new opportunities.

How It Started

October 2024 marks 15 years in business for FDAQRC and the company’s growth continues to reach new heights in the quality and regulatory compliance space. FDAQRC was founded in 2009 by Christopher Rush in efforts to provide an advanced approach to matching consultants and auditors with regulatory compliance projects. To date, FDAQRC has expanded its team and service offerings, building on a strong reputation for excellence in the industry.

At FDAQRC, we prioritize integrity, loyalty, and ethical practices in every business transaction, ensuring that we treat all customers with the utmost respect. Due to FDAQRC’s reliability and high quality of work, over 85% of our clients return with new projects and requests. FDAQRC employees offer our clients excellent customer service, expertise, and timely project deliverables, which keeps our clients coming back.

FDAQRC is known for our global consultant network consisting of former Food and Drug Administration (FDA) and European Medicine Agency (EMA) officials, Qualified Persons (QPs), and other Regulatory Affairs experts and has seen continuous growth over the past 15 years. As of 2024, we have vetted over 500 consultants across more than 70 countries.

Expanding Our Business 

In 2024, FDAQRC expanded its global reach to better support clients in Europe by adding a Qualified Persons (QP) service. QPs are certified experts to help clients navigate regulations for exporting biotech and pharmaceutical products to the United Kingdom and European markets. QPs can address regulatory compliance, audits and inspections, supply chain management, batch certification, and release and much more. With QP services being in high demand, FDAQRC opened a branch in Northern Ireland to be more accessible for our European and UK clients.

Additionally, FDAQRC noticed an uptick in Inspection Readiness requests. With the increasing complexity of regulatory requirements, Inspection Readiness audits have become essential to ensure that companies are fully prepared for any regulatory review. These audits identify gaps and potential risks before an official inspection occurs, minimizing the chances of delays or non-compliance issues. Due to FDAQRC’s global access to FDA, EMA, and other health authorities, our team can tailor each program to meet the unique needs of our clients.

FDAQRC also debuted a Trusted Partners program this year. Companies who are FDAQRC Trusted Partners share our commitment to excellence and innovative solutions in our field. By giving our seal of approval, clients know they can confidently partner with these companies and receive high quality results.

Quri.AI was the first Trusted Partner to be announced. Quri.AI harnesses the power of an AI engine to improve patient matching in clinical research. Their HIPPA compliant AI search feature allows researchers to filter through patient charts with specific inclusion and exclusion criteria to find the best candidates. to learn more about Quri.AI, click here.

With plenty of time left in 2024, FDAQRC plans to continue their growth trajectory through new avenues and service offerings. These past few months, FDAQRC has been focusing on new growth opportunities, which will likely lead to an exciting announcement as early as November 2024.

Our People: Building Culture and Connections

At FDAQRC, company culture is at the heart of everything we do. We value investing in our employees, helping them reach their goals and encouraging professional growth.

In the last year, FDAQRC added two new employees to the internal team. We hired a new Auditor to increase internal capabilities and created a new Executive Assistant position to better support management.

In February, the FDAQRC team met up for our annual Face-2-Face meeting in Costa Rica. Everyone enjoyed collaborating in person. Staff had the opportunity to unwind as a group and participate in some team bonding activities. For more info, check out our full Face-2-Face recap here.

With a fully remote team, FDAQRC plans fun initiatives for internal employees throughout the year. These events allow everyone to get to know each other and connect outside of work. We host a monthly coffee break for the team to join and enjoy a casual chat. We celebrated Mental Health Awareness Month in May by sharing valuable resources and practicing mindfulness. The FDAQRC team also participated in a little friendly competition for Wellness Month in August to prioritize holistic wellness by tracking various healthy habits and activities. As a group, we managed to take 942,289 steps!

In addition to internal events, attending industry events allows internal employees to stay up to date on important industry trends and take part in discussions about where the industry is headed. FDAQRC exhibited at SQA’s 2024 Conference and DIA’s 2024 Global Annual Meeting earlier this year and will be exhibiting at RQA’s International Quality Conference in November. We value the opportunity to attend these major conferences because it offers a chance to connect with clients and consultants in person and make new network connections.

FDAQRC’s company culture involves hard work, collaboration, and supporting one another. We value the personal relationships built between employees and practicing good work-life balance. We wouldn’t have experienced such great success and growth without the amazing staff at FDAQRC.

Thank you to everyone who has supported FDAQRC over the past 15 years. Without our outstanding clients, consultants, and internal team members, we would not have been able to reach this level of success. We look forward to continued growth and collaboration for many years to come!

Exciting things are in the works for Q4 2024 here at FDAQRC. Keep an eye out for an exciting announcement coming soon!