Services

CATEGORY: US FDA & EMA Compliance

The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have a common goal: “to protect public and animal health by ensuring that all medicines available on the USA and EU markets are safe, effective and of high quality”.  This goal is also common to any regulatory agency in the World, however, we mainly emphasize the roles of FDA and EMA because their regulations extend to every corner in our planet where a medical or medical-related manufacturing plant exist.

 

With that being said, it becomes clear that we are inviting you to treat both regulatory agencies as your most important clients.  Let’s take, for instance, the case of the FDA: whether you agree with us or not, it has been demonstrated that, as long as you are able to navigate through the web of Federal Regulations and remain cGMP compliant, you will largely ease your path toward current and prospective clients.  Not being PERFECTLY in compliance with these regulations pose a great risk for your organization to lose EVERYTHING.  By “losing everything” we mean that you won’t even be allowed to open another FDA-regulated facility just by using a different name.  That is why it is so important for upper management and employees to stay at the top of this game.

 

There is a close correlation between being GMP compliant with increase of customers, production, and of course, revenue and profits.

 

Give us the opportunity to work together and to help you built or maintain a strong Quality System in such a way that your company will quickly experience the benefits of being GMP compliant and be ready to grow exponentially.  Unlike most consulting firms in this field, our compliance consultants have Ph.Ds. and post-doctorate degrees in the fields of Chemistry, Organic Chemistry, and Biological Sciences.  Our qualifications and experience have been important assets for us to EXCEL in this industry and we pride ourselves by providing you a large set of valuable transferable skills that have been acquired along our professional path.

 

The SAR Group has been working closely with the FDA, which has recognized our credentials as an important GMP consulting resource for small and medium size manufacturing companies in South Florida.  The most outstanding praise we had received from this organization is that we are more than able to pull out a comprehensive investigation that results in adequate sets of Corrective and Preventive Actions (CAPA).  Needless to say, inadequate investigations and CAPAs have been one of the top reasons for 483 observations by the FDA since 1997.

Some of the services that our group provide in this Category are:

cGMP audits.  This include the review of:

  • Facility(ies)

  • Regulatory Documentation

  • Quality System(s)

  • Equipment System

  • Production System

  • Validation/Qualification System

  • Laboratory Control System

This will result in a GMP Practice Assessment Report, in which you will find the following responses:

  • All relevant non-compliant observations, being evaluated as:  Critical, Major, and Minors.

  • A Risk/Gap analysis report.

  • The Facility Performance Rating given by our group.

  • Performance Trend Analyses.

  • Recommendation for Improvement and Improvement(s) Plan Timeline.

If you are in need of a service not listed here but associated with this Category, we highly encourage you to contact us by following the link below ...

307 SW 16th Ave, Suite 301

Gainesville, FL 32601 U.S.A.

info@theSARgroup.com

Tel: 786.514.6171

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