QUALITY MANAGEMENT & COMPLIANCE

Translate Regulatory Guidance into Proactive Strategy

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To get your company on the right track from the beginning, it’s vital that you use regulatory guidance to determine proactive steps and preventive procedures.

In confirmed non-compliance situations, such as FDA 483 letters or FDA warning letters, Ayd Group identifies root causes and pair them with specific solutions as part of a customized remediation master plan. Our facilitation of implementation of the remediation plan will get you back on track to where you should be.

SERVICE OVERVIEW

Quality

For pharmaceutical, biotech and medical device manufacturers, Quality Management Systems (QMS) are the foundation for enabling the organization to operate in a compliant manner. The QMS embracing the principles of the International Conference on Harmonization Q10 (ICH Q10) model establishes the path toward compliance for the company and enables sustainable systems that meet the demands of regulators, customers and ever-changing business environments. Ayd Group is a trusted partner in designing and building QMS programs. We can help guide your team through the regulatory processes specific to your quality programs.

Compliance/Remediation

For many companies, a strong alignment with a reputable remediation partner is often a vital first step toward restoring the confidence of regulatory agencies, shareholders, consumers and other stakeholders. Ayd Biopharma Consulting Group specializes in remediation and regulatory compliance consulting. We have collaborated with FDA-appointed overseers and life sciences client executive leadership to help avoid and/or remediate issues related to FDA 483s and warning letters.

Our flexible, consultative model enables us to provide expertise, resources and comprehensive project management throughout a remediation engagement, either by augmenting staff or by planning and executing a major, multi-year project.

 

Our Quality Services include:

  • Quality Management Systems (QMSs)
  • Develop and Review Quality Agreements
  • Author/Draft Standard Operating Procedures (SOPs), Company Policies, Work Instructions and Supplemental Forms
  • Training Programs
    • Good Clinical Practices (GCP)
    • Good Documentation Practices (GDP)
    • Good Laboratory Practices (GLP)
    • Good Manufacturing Practices (GMP)
    • GxPs overview (Includes GCP, GDP, GLP and GMP)
    • Customized modules/group training available for sales and marketing individuals

Our Compliance/Remediation Services include:

  • Assist with FDA 483 and Warning Letter Remediation
  • Manage Communication with Regulatory Agency
  • Coordinate Response Content and Effort

CASE STUDY

Drug Supply Chain

US Drug Supply Chain Security Act (DSCSA): How Medical Device Manufacturers Must Comply — Planning ahead for unexpected regulatory implications down the road.

RESOURCES

US FDA Guidance Document: “Data Integrity and Compliance with CGMP Guidance for Industry” DOWNLOAD

US FDA Presentation: “CGMP Case Studies” — Regulatory Education for Industry (REdI): Focus on CGMPs & FDA Inspections DOWNLOAD

Sample Engagements

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Completed a risk assessment of a medical device company’s supply chain, wholesale distributors and third-party logistic providers for compliance with the Drug Supply Chain Securities Act (DSCSA). Identified gaps and proposed remediation solutions, which, when implemented, addressed the compliance issues.

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Partnered with a law firm to define regulatory requirements needed to govern a philanthropic gift-funded, multi-party research initiative aimed at finding a glioblastoma cure. Multiple hospital networks, researchers, clinicians and PIs were involved. Emphasis was placed on potential conflicts of interest, duty clarification and clinical trial oversight. Customized GxP agreements were drafted and executed and the initiative commenced.

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Succeeded in getting a compounding company out from under a two-year FDA warning letter for selling an unapproved drug. Negotiated directly with senior FDA officials to reach agreement that, upon successful completion of a bio-equivalency study, submission of an NDA application and FDA approval, the warning letter would be lifted. This occurred and the client was then able to commercially sell product and generate new sales revenue the same year after nearly two years with no sales.

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Worked directly with the CEO of a large life sciences consulting firm that was being restructured and simultaneously undergoing a rebranding effort. Using a small team of subject matter experts, we developed a customized GxP training program targeted specifically for the sales and marketing team which numbered >70 employees. Training was successfully completed on time and on budget.

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In another warning letter situation, succeeded in implementing a remediation strategy resulting in resolution of portions of the warning letters. This allowed for restoration of partial production capability, allowing essential drug products to be released to the market during a drug shortage and generating sales revenue for the pharma company.

Get Your Company on the Right Track from the Beginning.

Together, we can design a Quality and Compliance strategy to keep you there. Let’s have a quality conversation.

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