Services

Regulatory Consulting

Is navigating through the complexities of regulatory compliance a challenge? 

Are you concerned about FDA or Industry self-policing programs detecting gaps? 

You want confidence that you have a strong resource to develop processes that will reduce risk and continually drive improvement thereby winning loyal customers.  

Gap Analysis & Auditing

Are you harboring concerns about what might be happening on the manufacturing floor?  Are you certain your processes are compliant with FDA regulations?

Enlisting the perspective of an impartial observer can unveil any existing gaps in your processes, providing you with a valuable opportunity for enhancement.

Manufacturing Enhancement

If you find yourself grappling with challenges in enhancing your manufacturing process or feel uncertain about the implementation of quality systems, Forefront Quality Solutions is here to collaborate with your team. Our expertise is geared towards identifying improvements in your existing processes that can significantly inflate your bottom line.

Regulatory Consulting

We understand that navigating regulatory and certification requirements can be daunting.  Forefront Quality Solutions’ expertise can assist you with any challenges you may have.

  • Registration and certification assistance

  • FDA remediation (for 483s, warning letters, labeling and website reviews)

  • Regulatory compliance

  • Quality management system development and Standard Operating Procedure (SOP) creation

    • Document control – for all types of documentation

    • Change Control – revision review and approval

    • Customer Complaint

    • Non-conformance/Deviation

    • Risk Analysis

    • Root Cause Analysis (RCA) and Corrective and Preventive Action (CAPA)

    • Validation

  • Formula and labeling review

    • Product dossier development

  • Allergen Management systems

  • Recall assistance

Gap Analysis and Audit

Review and assessment can give you peace of mind your internal systems are meeting expectations and requirements.  At Forefront Quality Solutions our assessment services extend beyond your internal operations to encompass your contract manufacturing organizations and component suppliers. 

  • On-site Gap audit

  • Contract Manufacturing/Packaging Operation (CMO/CPO) assessment

  • Component supplier audit

  • Contract Laboratory qualification

Forefront Quality Solutions offers reasonable pricing starting at $2500 plus expenses. Contact us to see how we can help give you an assurance your supply chain does not pose any risk.

Manufacturing Enhancement

Have your processes been formally developed to guarantee the proper implementation of inspections based on the risks they pose? Has data been systematically collected and reviewed to ensure that your shop floor maintains a state of control? Embracing a continuous improvement mindset is crucial for manufacturing success. Whether it's conducting an incoming material assessment, overseeing the processing phase, or conducting a final product review, our team is prepared to provide assistance at every step.

  • Quality core tools

  • Failure Mode and Effect Analysis (FMEA)

  • Quality Management Systems (QMS)

  • Statistical Process Control (SPC)

  • Root Cause Analysis (RCA) and Corrective and Preventive Analysis (CAPA)

  • Sampling strategy creation

  • Quality Technical Agreement development

  • Standard Operating Procedure (SOP) writing

  • Change Control systems

  • Supplier Qualification and on-going performance tracking