cGxP

Consulting

 

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Core Services:

7 Steps to Practical Compliance

21'st Century cGMPs

Risk Based Design Controls

Validation/ Characterization Qualification Services
7: Regulatory Submissions/Responses

6: Reinforce & Assist

5: Validation/ Qualification Services

4: Customized Training

3: Project Management

2: QSIP: Negotiation/Remediation

1: Quality Systems: Audit & Assessment
 

 

cGxP has been at the forefront of 21'st Century cGMP Design Control Tools.  We have two days courses in Risk Management, Risk Assessment, Design of Experiments, and Statistical Process Control.  We can help your organization integrate these new tools into your product development process.

21'st Century Tools

Training

 

 

   

Test Method, Product or Process Validations are critical steps necessary to assure that a product will be safe and effective under the actual conditions of use.  Lack of appropriate Characterization, Qualification or Validation is the major source of regulatory actions Worldwide. 

Validation Services
 

 

 

   
Serving the Drug, Device, and Biotechnology Community 

Practical Compliance- Safe Harbor

cGxP is Practical Compliance and offers you "Safe Harbor."  cGxP has the multi-disciplinary capabilities to provide the medical device &

biopharmaceutical industries comprehensive services spanning the entire product life cycle.

 

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