Complete projects on time and on budget with industry-leading life science consultants and specialists.

We offer remediation support, auditing, training, regulatory and expert witness services to the pharmaceutical, biotechnology, medical device, and diagnostics industries. Explore our areas of expertise to learn how we can help you evaluate, correct, and maintain your quality system and much more.

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Our Proven Process

Introductory Conversation

  • You learn about us, we learn about you and the type/scope of work you need.

Resources Definition

  • You tell us who you need in terms of background and expertise, where you need them, and we rightsize the rate for your budget.

Proprietary Talent Selection Process

  • We tap into our pool of internal and external specialists and identify the perfect resource.

Specialist Presentation

  • You receive a CV, perfect-match summary, and we coordinate the interview.

Agreement Processing

  • We collaborate on the Master Service Agreement and Addendums, supplier qualification, and coordinate kickoff.

Account Management

  • You receive dedicated project and satisfaction management throughout your project/program supported by a Total Quality Guarantee.

Area of expertise Remediation Support

Our experienced quality professionals take a hands-on approach to solving quality and compliance issues by developing and implementing comprehensive quality system remediation projects. This may be in response to your own internal audits or a recent inspection by FDA or your Notified Body.

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Area of expertise Auditing Services

We pair you with former FDA and industry professionals with extensive knowledge of the FDA's current inspection expectations to ensure you're meeting all FDA regulations.

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Area of expertise Training Sessions

Our large group of former FDA officials and industry experts lend decades of experience and intimate knowledge of the regulatory environment through customized FDA training programs. We design our training sessions to help your organization master the complexities of drug, device, and biologic compliance.

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Area of expertise Regulatory Affairs

Our regulatory affairs specialists have years of experience working with the FDA throughout the pharmaceutical, biotechnology, medical device and diagnostic industries.

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Area of expertise Expert Witness

Our expansive staff of expert consultants ensures you will be paired with the right expert for your specific case.

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See your project through to success with exactly the resource you need, guaranteed.