FDA Compliance

Is FDA Compliance your biggest worry ?

In these days of increasing government regulation and public awareness in the pharmaceutical industry, it is important that we all understand the special care required in the manufacture of our products. Is your organization geared up to provide that care? Are you concerned about your organizational compliance with FDA / DEA requirements? May be you should take a moment to examine the following questions:

• Is your organization ready for an FDA’s Pre-Approval, For cause or General Inspections?
• Do you have a company policy to deal with FDA?
• Are you looking for ways to efficiently use your training resources?
• What is your level of confidence that all your control systems comply with cGMPs?
• Do you have experts on staff to do this job efficiently?
• Do you need an independent peer review of your ANDA fillings and responses to FDA?

The response to these questions may hold the key to your company’s continued success and Pharmax Group, Inc.(PGI) can help you achieve this goal.