Focused on delivering tangible and useful work products on time, in full
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We are committed to consistently delivering outcomes that meet our clients’ specifications and requests and also meet all applicable regulatory requirements and quality standards
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We are able to quickly learn your products, processes and business model
Timely
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We prepare realistic proposals, estimates and project plans and deliver on schedule
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Once engaged we respond promptly to your calls and emails
Led by industry veteran Charmaine Sutton
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20+ years consulting in medical devices, directly interfacing with global regulatory authorities
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7 years as Global VP Operations and Regulatory Affairs for $150 million global medical device firm
Knowledge
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We are up to date on and fluent in current and emerging regulations, guidance, and standards in the US, Canada and the EU
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We are highly attentive and acquire a detailed understanding of your business
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We have degrees in physics, biology, regulatory affairs, and public health.