295 COOPER RD BAY CREEK BUSINESS PARK LOGANVILLE, GA 30052 Get Directions
295 COOPER RD BAY CREEK BUSINESS PARK LOGANVILLE, GA 30052 Get Directions
The Smith Life Science Law Group focuses on providing competent, flexible services to meet the legal and business needs of FDA regulated clients. Building on significant industry experience, the firm represents and advises clients in all matters related to product research and development, and commercialization. Our services include: Advising pharmaceutical, medical device, and biologic clients regarding regulatory and transactional matters associated with the development and commercialization of products, including regulatory compliance and privacy matters. Managing domestic and international multi-site clinical research, including CRO and site contracting, IRB filings and regulatory compliance. We also advice on import/export matters and foreign representative issues. Providing analysis and advice related to applicable regulations regarding the FDA regulatory process including, by way of example, Food Drug and Cosmetic Act, FDAAA, cGMP, GCP, and HIPAA.
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