working globally and

ensuring safety in the medical field.

Our expert consultant has a vast amount of experience getting medical devices approved and ready for sale on the market. He’s worked with some of the biggest companies in the industry and can work internationally. That’s right, Global Strategic Solutions is truly global. We can provide our services in the USA, Asia, Europe, wherever there are medical device companies! With our help, you can find the quickest and most affordable route to approval.  

working globally and

ensuring safety in the medical field.

Our expert consultant has a vast amount of experience getting medical devices approved and ready for sale on the market. He’s worked with some of the biggest companies in the industry and can work internationally. That’s right, Global Strategic Solutions is truly global. We can provide our services in the USA, Asia, Europe, wherever there are medical device companies! With our help, you can find the quickest and most affordable route to approval.  

Trusted Globally

Highly experienced

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Cost efficient

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Fast turnaround

Looking For An International Consultant For Medical Manufacturing?

Is your company struggling with getting a medical device approved globally? Are you having urgent approval issues with the European Union or China?  Then you’re going to love what we do at Global Strategic Solutions! We know that the approval process can be a stressful time for any company. Our founder has worked through this process for over 25 years and has it down to a science. With our help, we can get your product through the approval process and into the hands of customers that need it! We’re an international consultancy focused on medical devices.

Consulting Services

In short, if your medical device company wants to save time and money during the approval/manufacturing process, you need to try out our services!

Clinical, Regulatory, and Quality Services

We know that the approval process can be a stressful time for any company. Our founder has worked through this process for several years and has it down to a science.

With our help, we can get your product through the approval process.

We’re an international consultancy focused on medical devices. Our services include: – Medical device consulting – Guidance through the approval process – Consulting for Class I, II, and III medical devices – Consulting for purchasing, manufacturing, and marketing of devices – 24/7 email support – Over 25 years of experience and expertise in the medical industry  and more!

a high bar for quality....

the most brilliant clinical-regulatory directors I know of. 

Kunal Sampat, MNA, ACRP-CP

President & CEO at Global Strategic Solutions, LLC

David R. Rutledge

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David R Rutledge, Pharm.D., FCCP, FAHA is a results-oriented consultant for clinical evaluation and investigation, clinical risk management, regulatory, and quality.  He brings 25 years’ global experience and has managed budgets up to $23.3 million. David qualified as an EU Person Responsible for Regulatory Compliance (PRRC) March 2021.

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GET IN TOUCH

Do you run a medical device business struggling with the approval process? Would you love an expert international consultant for medical devices? Great! Then you’re a perfect fit for what we do at Global Strategic Solutions!

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About us

25 years’ global experience with agencies such as US FDA, Brazil ANVISA, Mexico COFEPRIS, NMPA (China FDA), S Korea Ministry of Food and Drug Safety, Hong Kong, Malaysia, Health Canada, Australia TGA, Thailand FDA, Japan PMDA, EMA, Saudi FDA, CDSCO of India and several Notified Bodies. Qualified EU Person Responsible for Regulatory Compliance (PRRC) 

Contact Info

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Based in Silicon Valley, CA

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