We're specialists in regulatory compliance for the United States in world-class pharmaceutical
companies.
Qugeneron is a premier firm owned and led by former FDA Investigators, providing an unmatched perspective on compliance and regulatory strategies. Partnering with us means choosing a team that not only understands the intricacies of FDA regulations but also has direct experience in shaping these guidelines.
We have the most robust network of former FDAers, who with experts in the pharmaceutical industry, with more than 20 years in the field, are committed to providing the most accurate solutions towards the excellence of regulatory compliance. Our firm can provide accredited consultants that include: Former FDAers, Chemical—Mechanical-Industrial Engineers, Chemists, microbiologists, GMP/SOP Experts, & Organizational Consultants with proven track record in the pharmaceutical & lifesciences industries.
Our team of experts brings extensive knowledge and hands-on experience ensuring our clients receive the most accurate and up to date guidance in navigating complex compliance requirements.

We are specialists in regulatory compliance

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Mission Statement:

At Qugeneron, our mission is to be the leading partner in ensuring pharmaceutical companies worldwide achieve and maintain the highest standards of regulatory compliance.

Through unwavering dedication to integrity, innovation, and expertise, we are committed to safeguarding public health and empowering our clients to deliver safe, effective, and reliable products to the global community.
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Core Values:

We uphold the highest ethical standards in every aspect of our work, promoting transparency, honesty, and accountability in all interactions with our clients and regulatory authorities.

Integrity

Collaboration

Commitment to Public Health

Positive impact on pharmaceuticals

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Qugeneron Vision

To being the premier regulatory compliance partner, helping pharmaceutical companies navigate the complexities of the regulatory landscape and ultimately contributing to the betterment of public health on a global scale.

Our Promise

We demystify the regulatory landscape for your businesses, ensuring that you not only stay compliant with FDA standards but also remain competitively innovative. Our team of seasoned experts works diligently to keep abreast of the latest regulatory developments, providing you with proactive solutions that secure your business's present and future.
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