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Regulatory Affairs

NovoTek has superior experience on regulatory requirements in China and we understand the numerous difference between Chinese healthcare regulation and those found in the US and Europe. Taking advantage of our knowledge and our case-by-case design of product development and marketing strategies will greatly simplify your entry into China.

Our regulatory services include the following major aspects
• Regulatory strategy design for imported pharmaceutical products (including small molecules and biological drugs) • Regulatory strategy design for imported medical device and IVD
• Review and consulting on importation filing package
• Review and consult on clinical trial protocols
• Risk evaluation on obtaining drug and medical device importation certificate
• Risk Renew application for pharmaceuticals and medical device importation certificates
State-of-the-art animal facilities with US compliance, fully functional on formulation, bio-analyses, PK studies, pharmacology studies, toxicity studies and data analyses.
Professional team presiding over strictly regulated operations; APIs from our customers are strictly controlled and protected.
Capabilities to carry out studies on mice, rats, rabbits, dogs and primates.
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