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FDA CDER Small Business and Industry Assistance (SBIA)
FDA CDER Small Business and Industry Assistance (SBIA)
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Medical Affairs *
Scientific Communications Development
Strategic Stakeholder Engagement
Defining the Value of Medical Affairs
Evidence Generation
Strategic Communications Planning
Regulatory *
Labeling & Promotions
Maintenance & Renewals
Compliance
Transparency & Disclosure
Commercialization *
Customer Engagement
Brand Planning & Activation
Market Access & Policy *
Government Policy
Global Market Access
Pharmacovigilance *
Safety Systems
Risk Management
Finance & Investment *
Financial Services
Investment Banking
Quality & Mfg *
Facilities & Equipment
Testing & Release
Quality Management
Production & Supply Chain
Clinical Research *
Real World Data Research
Study Operations & Management
Clinical Reporting
Product Development
Trial Design & Planning
Technology & Operations *
Automation & Efficiency
Data & Analytics
Early Development
Digital Health Solutions
Operations
Informatics Infrastructure
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Projects
Medical Affairs *
Scientific Communications Development
Strategic Stakeholder Engagement
Defining the Value of Medical Affairs
Evidence Generation
Strategic Communications Planning
Regulatory *
Labeling & Promotions
Maintenance & Renewals
Compliance
Transparency & Disclosure
Commercialization *
Customer Engagement
Brand Planning & Activation
Market Access & Policy *
Government Policy
Global Market Access
Pharmacovigilance *
Safety Systems
Risk Management
Finance & Investment *
Financial Services
Investment Banking
Quality & Mfg *
Facilities & Equipment
Testing & Release
Quality Management
Production & Supply Chain
Clinical Research *
Real World Data Research
Study Operations & Management
Clinical Reporting
Product Development
Trial Design & Planning
Technology & Operations *
Automation & Efficiency
Data & Analytics
Early Development
Digital Health Solutions
Operations
Informatics Infrastructure
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10001 New Hampshire Ave, Silver Spring, MD 20903-1707, USA
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FDA CDER Small Business and Industry Assistance (SBIA)
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Guiding Your Pharmaceutical Success Through FDA Expertise and Support
The organization operates as a dedicated division within the U.S. Food and Drug Administration, focusing on providing support and resources to small businesses and the pharmaceutical industry. It serves as an essential conduit for navigating the complex landscape of drug regulation, offering guidance on FDA-approved drugs, including their regulatory history, usage, and compliance requirements. By extending comprehensive assistance in the realm of human drug products, the entity ensures stakeholders have access to accurate, timely information necessary for successful market participation.
Additionally, the organization stands as a crucial first point of contact for emerging businesses in the pharmaceutical sector, fostering a clear understanding of FDA procedures and drug product regulations. It aims to demystify the regulatory process by offering detailed insights into product approvals, safety information updates, and changes in federal requirements. By facilitating effective communication between regulatory bodies and the industry, the entity plays a pivotal role in promoting informed decision-making and sustainable business growth within the pharmaceutical landscape.
Guiding Your Pharmaceutical Success Through FDA Expertise and Support
The organization operates as a dedicated division within the U.S. Food and Drug Administration, focusing on providing support and resources to small businesses and the pharmaceutical industry. It serves as an essential conduit for navigating the complex landscape of drug regulation, offering guidance on FDA-approved drugs, including their regulatory history, usage, and compliance requirements. By extending comprehensive assistance in the realm of human drug products, the entity ensures stakeholders have access to accurate, timely information necessary for successful market participation.
Additionally, the organization stands as a crucial first point of contact for emerging businesses in the pharmaceutical sector, fostering a clear understanding of FDA procedures and drug product regulations. It aims to demystify the regulatory process by offering detailed insights into product approvals, safety information updates, and changes in federal requirements. By facilitating effective communication between regulatory bodies and the industry, the entity plays a pivotal role in promoting informed decision-making and sustainable business growth within the pharmaceutical landscape.
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a Vice President Business Development
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a Senior Manager Regulatory Affairs
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Locations (1)
Silver Spring Location
10001 New Hampshire Ave, Silver Spring, MD 20903-1707, USA
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