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REGULATORY GUIDANCE FOR EMERGING PRODUCTS

We have the expertise to overcome the hurdles of quality standards and regulatory compliance.

FDA Compliance
INDUSTRY
ORGANIZATIONS

FDA
DailyMed
Board of Pharmacy

Assay Testing and Method Validation
FORMULATION
ASSURANCE

COA's
Assay Testing
Method Validation

cGMP and Quality Compliance
QUALITY
COMPLIANCE

cGMP
CFR 21
NABP

Our team has an extensive history of bringing products to market. We understand the critical importance of adhering to stringent regulatory guidelines and staying updated with current practices. Through a proactive combination of planning, documentation, and communication with all regulatory authorities, we facilitate market launch in a timely manner without compromising product safety or product quality.
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