GMP Consulting

Leadership in Action

 

With a long history of successful interactions with the FDA and other regulatory agencies, Frontage helps you manage the challenges of Current Good Manufacturing Practices (CGMP).

 

The Frontage team has guided clients through more than 25 FDA inspections, including API and finished product inspections of Chinese facilities.  Our team includes industry veterans with product launch experience and backgrounds in development, scale up, validation and regulatory.

 

 

 

Our CGMP services operate on a global scale with offerings that have played an important role in numerous international markets.  For instance, we have helped secure some of the first time US FDA approvals of finished dosage forms and Active Pharmaceutical Ingredients manufactured in the USA, China, Spain, Germany, South America, and India.

 

 

A Philosophy of Team Building

 

The Frontage consulting philosophy involves team building and true partnerships that combine substantial training with extensive project work.  As a trusted partner, our goal is to improve the expertise of your company’s leadership so that compliance is built into every operations process.

 

Frontage helps you understand “the why” behind “the what” of CGMP regulations.  With this knowledge and the practical experience of working with Frontage, your operations and submission processes will run more smoothly.

 

Depending on the strengths and weaknesses of your team, Frontage can develop a customized approach to get your company ready for foreign inspections, foreign and domestic regulatory filings and product launches. 

 

Our engagements can include:

 

  • GMP Audits and System Development
    • Initial GMP/GLP gap assessment of Company & Operations
    • Periodic reviews of remediation progress and FDA readiness
    • GMP and Quality System Training
    • Inspectional and Deficiency Letter Remediation
    • Compliance System Development

     

  • Project Management for Facility Design, Engineering and Commissioning

    • Quality by Design Concept & Basic Design projects
    • GMP Facility Layouts and Equipment Qualification
    • Engineering Support  - Coordination with Engineering Firms & Design Institutes
    • On-site Commissioning & Qualification Teams

 

  • Product Development, Technical Transfer, and Scale-Up Oversight

    • Submission batch / biobatch monitoring

    • Quality by Design experimental plans

    • Process Validation Support

    • Regulatory Filing Support