We help our clients achieve their goals by providing unmatched value and service to design an efficient solution that best meets your needs:

• Presentations and training on Drug Safety, Pharmacovigilance, Benefit-Risk Assessment, Risk Management, Pharmacoepidemiology at client's site
• Handling of Adverse Event Reports, Data Collection/Reporting, Data Processing, Medical Review, Accurate and timely submission of FDA / Worldwide Regulatory safety reports, including 15-Day Expedited Reports, Periodic Reports, and Periodic Safety Update Reports (PSURs), Annual Safety Reports
• Risk Management Plans, Signal Detection, Benefit-Risk Analyzes, Regulatory Reports, Process Review and Improvements, Legal Review, Deposition Training, Preparation, Expert Witness Services
• Development of Core Safety Information, Product Labeling, Pregnancy Registries, Patient Support Programs, Audits/Inspections, mock audits, FDA Warning Letters/483s/EIR Reports, Corrective Action Plans, Product Recalls, Assistance at government inspections, Crisis Management and Business Continuity
• Change Management, Re-engineering of Pharmacovigilance, Medical Writing, White Paper preparation, Regulatory strategy, Assistance at meetings with Regulators, Off-shoring and out-sourcing including call centers

Our Credibility is Solid:
We not only consult with you, but we maintain an active and substantial hands-on practice in the areas which will serve you best.

Our Services are Invaluable:
Working with you, we can educate and help you coordinate your efforts and strategy with our broad network of experienced Drug Safety Experts to assist in finding whatever other help you might need.

Unsurpassed Expertise:
Our clients include a wide range of companies including Pharmaceuticals, Biotechnology, Generics, and Consumer Healthcare.

We are Results Oriented:
We help to identify the strengths, as well as the weaknesses and pitfalls, for optimal resolution of all issues.

American HSC was formed with One Vision:
We have demonstrated an unwavering commitment to our clients. We are guided by the principle that each project calls for the right combination of commitment and attention to detail along with a dedication to integrity and professionalism.

Our Philosophy is Simple:

• Confidentiality
• Commitment to Quality
• Uncompromising Service
• Personal Responsibility