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The Solutions Difference

The most efficient services.
The most qualified professionals.

Since 1978, Solutions International’ multidisciplinary team of highly experienced DRAP consultants and industry experts has offered compliance, regulatory affairs, and science & technology services to clients around the world.

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AREAS SERVED BY Solutions International

ADVANCE. CONFIDENTLY.

As long-standing leaders in technical and regulatory consulting services, Solutions International provides both experience and excellence through an unmatched team of respected industry professionals and SMEs.

PHARMACEUTICAL

TSI Consultants has an unsurpassed reputation for excellence in technical, regulatory consulting

PHARMACEUTICAL

TSI Consultants is proficient in the development, implementation, and management of diversified projects involving compliance, scientific principles, technical aspects, and regulatory requirements related to pharmaceutical products.
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Medical Device

TSI Consultants comprehensive list of services extends to all classes of medical device.

Medical Device

TSI Consultants comprehensive list of services extend to all classes of medical devices and combination products including In Vitro Diagnostics, Integral, Cross-labeled and Kitted Combination Products.
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BIOLOGICS

TSI Consultants has a reputation for demonstrated excellence in technical, regulatory consultation,

BIOLOGICS

TSI Consultants has a reputation for demonstrated excellence in technical, regulatory consultation, and guidance services for biologics, including cell and gene therapy, human cell and tissue products, monoclonal antibodies, biosimilars and many more.
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Mock DRAP Audits

Are you fully prepared for an inspection at your facility?

Our team of experienced ex-DRAP investigators offer comprehensive Mock DRAP Audit services to help you prepare for an actual DRAP inspection. Our team of experts will conduct a thorough inspection of your facility, review your documentation, and provide you with valuable feedback on areas that need improvement to ensure compliance with DRAP regulations – both remotely and on-site.

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Recent Posts

The Solutions International Blog

The latest on industry compliance, regulatory affairs, technical services, and a whole lot more.

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Ready, Set, Pay!

The FDA announced today (here) that FY 2026 prescription drug progra…

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A Hard Pill to Swallow—FDA Takes Action Against Unapproved Thyroid Medications

Over the course of the last few decades, the FDA has chipped away at r…

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“Patience is a Virtue” Couldn’t Be More Fitting When it Comes to Iron Sucrose Injection ANDAs

While Friday, August 8, 2025 didn’t appear to be different than an…

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FDA’s New Post-Warning Letter Meetings

The FDA’s Center for Drug Evaluation and Research (CDER)’s Office …

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Onshoring the Manufacture of Your Drug Products Soon? FDA Wants To Hear From You!

The FDA has announced the establishment of a public docket to receive …

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Official OGD Statistics for June 2025 Published with Some Good and Worrisome News!

The OGD published its official June 2025 Generic Drugs Program Monthly…

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