Capabilities

We Speak Science℠

Whether a project requires a clinical protocol in a specific therapeutic area or consultation on a validation protocol for a chemistry, manufacturing, and control (CMC) process, WI offers a uniquely integrated approach for communicating complex corporate and scientific messages. At WI, we provide pharmaceutical, device, and biotechnology clients with a full spectrum of comprehensive services accommodating any writing need. Our approach capitalizes on the expertise, education, and industry experience of WI’s team of medical writers and group of CMC specialists. We provide clients with a wealth of industry resources and the skills to deliver projects as promised.

Our Team Is Your Team

Collaboration and communication are key tenets of our process. Whether we are tasked with preparing full submissions to the FDA or international regulatory agencies, editing a single document, or performing a gap analysis of a technical package, our writers and consultants seamlessly engage with client teams to ensure the comprehensive, timely completion of each project.

Committed to Client Satisfaction

As a boutique group, WI offers superior customer service and a commitment to individualized attention.

Regulatory Writing

Regulatory Writing

Our expertise in regulatory writing is comprehensive.

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Clinical

Clinical

We’re at home with the common technical document.

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Non-Clinical

Non-Clinical

We create submission-ready Toxicology and Nonhuman Kinetics reports.

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Quality

Quality

We understand quality regulations.

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Publications and Education

Publications and Education

Need to publish? Need to educate?

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Government Contracts

Government Contracts

Whitsell Innovations is committed to exploring strategic partnerships with industry, academia, and government clients.

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Document Management

Document Management

We Speak Science, Securely.

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Strategic Consulting

Strategic Consulting

Consulting vs. Strategic Consulting?

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Therapeutic Area Expertise

Therapeutic Area Expertise

Our team approach provides expertise in all therapeutic areas.

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Safety and Pharmacovigilance

Safety and Pharmacovigilance

It’s More than Formatting Narratives.

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