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Quality and GxP Compliance

Supporting emerging pharmaceuticals and biotech companies from drug development to clinical success

Our Approach

At Cadoret Global, we forge client-centric partnerships, offering phase-appropriate and value-added Quality and GxP compliant consulting tailored to navigate the complexities of drug development. Our proactive approach and commitment to transparency support our clients’ transition from pre-clinical promise to clinical success.

FY2022 BIMO Compliance Snapshot

466

U.S. FDA Form 483s issued to drug establishments

72

cGMP Warning Letters issued 

20%

Sponsor firms issued FDA Form 483s

311

Clinical Investigators inspections conducted (CDER)

What we do:

Supporting drug development through:

  • Phase-appropriate, scalable quality systems

  • Vendor management and quality oversight

  • Foreign and domestic GxP audits

  • Batch record review and product release

  • Clinical supply chain management

  • EU QP strategy and independent audits

  • Privacy Governance

Working experience with

Explore how Cadoret Global can support your organization’s transition from pre-clinical to clinical

A message from our CEO.

I started Cadoret Global Inc. on the premise that consultants are partners invested in the success of their clients. This vision flourished through the years into bringing value, integrity and partnership to the biotech and pharmaceutical industry.

It is a privilege and honor to lead a team of expert consultants:

  • who understand GxP regulations and risk management,

  • whose core expertise includes the drug development lifecycle and phase-appropriateness,

  • who appreciate how quality is deeply intertwined with compliance, and

  • who are ultimately committed to the patient-centric development of life changing therapeutics.

We pride ourselves in being an integral part of our clients’ high-performing teams, providing both strategic and tactical support for companies navigating the fast-paced and ever-changing regulatory landscape.

Whether your company is transitioning from pre-clinical to clinical stage, from phase 1 to phase 2, or from late phase to commercial, we are committed to providing our depth of expertise and benchmarking to help you achieve your corporate objectives.

Our consultants are vetted and specially selected to deliver exceptional consulting services that embody our guiding principles: Collaborative, Adaptable, Driven, Organized, Reliable, Experts, Timely.

At Cadoret Global Inc., we understand our clients’ needs and are eager to share our experience and expertise to anticipate and overcome the challenges they will face.

It is an honor to lead an organization built on a foundation of value, integrity, and partnership. I am confident Cadoret Global Inc. will continue to stand out as a reputable and trustworthy cadre of consultants who are all in, and efficiently and effectively pave the way for their clients’ success.

  • "Overall, we are very impressed by the expertise, value, and partnership provided by Cadoret Global."

    “Cadoret Global has been the perfect QA partner for our company, a small pharma focusing on early-stage development. Enith and her team are very experienced in all aspects of CMC and Clinical Supply Chain. Cadoret helped us to establish our quality system, audited our global network of vendors, and oversaw numerous successful manufacturing campaigns. As a small company, we especially appreciate that Cadoret is always very responsive and resolved issues rapidly without compromising product quality. Cadoret also contributed significantly to the due diligence process that led to our successful acquisition by a big pharma company, who is completely satisfied with Cadoret’s work. Overall, we are very impressed by the expertise, value, and partnership provided by Cadoret Global.”

    TECHNICAL OPERATIONS - BIOTECH COMPANY

  • "You have managed to integrate all your expertise seamlessly and quickly into the greater company team. "

    "I cannot imagine a better way to start my foray into CMC and QA/QC than working with all of you [Cadoret Global team]. As you know, this was not (and still really isn’t) my expertise so I truly appreciate all your support, understanding and patience in explaining to me and the team what and why needs to be done when. I have full confidence in your ability to get business done on time and in the highest quality and in always keeping our success front-and-center in everything you do. You have managed to integrate all your expertise seamlessly and quickly into the greater company team. It is largely because of all your tireless contributions and your unwavering determination to succeed at solving difficult problems that our company is now able to plan on becoming a clinical company in early 2023.

    HEAD OF CMC - MEDICINAL CHEMISTRY CLINICAL COMPANY

  • "...integral part of the team"

    “Working with Enith and her team of experts at Cadoret Global has been such a pleasure. They understand how to build systems and processes that are phase-appropriate based on the stage of the company. They have been an integral part of the team in helping us manage through some key challenges successfully.”

    SENIOR VP- DEVELOPMENT, OPERATIONS and REGULATORY AFFAIRS COMPANY-

  • "... deep bench of drug development experts"

    “We all need to appreciate Enith's deep bench of drug development experts that she has assembled at Cadoret and has deployed promptly at our company on several occasions over the past year.”

    HEAD OF CMC - NEUROSCIENCE PHARMACEUTICAL COMPANY

  • "...patience and resilience "

    “During the last almost 3 years Enith has been an integrated member of our team and her great support to all CMC activities, willingness to take late night/early morning calls and travel/respond to multiple emergencies, as well as patience and resilience as we were navigating through many challenges are very highly appreciated.”

    HEAD - PHARMACEUTICAL DEVELOPMENT PHARMACEUTICAL COMPANY

Knowledgeable of international regulations and standards