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Riddle Compliance
Riddle Compliance

FDA Compliance Consulting

FDA compliance consulting services for growing organizations

At Riddle Compliance, we provide an extensive suite of FDA compliance services designed to navigate the intricate landscape of FDA regulations. Our team comprises a diverse group of interdisciplinary experts, including former FDA officials and seasoned industry professionals, bringing a wealth of knowledge and experience to address a wide range of FDA-related concerns. We specialize in understanding the complexities and nuances of FDA regulations across various sectors, including pharmaceuticals, medical devices, biotechnology, food production, and more.

Our holistic approach to FDA compliance goes beyond merely meeting regulatory requirements. We aim to empower our clients to exceed these standards, ensuring not only compliance but also operational excellence and market leadership. We understand that FDA compliance is a dynamic field, constantly evolving with technological advancements and regulatory changes. Therefore, we stay at the forefront of these developments, offering our clients the most current and effective compliance strategies.

Our services encompass a broad spectrum of FDA compliance areas, including:

  • Regulatory Strategy and Consulting: Strategic guidance on the FDA approval process for new products, offering insights into regulatory pathways.
  • Quality Systems Management: Implementing robust quality management systems that comply with FDA Good Manufacturing Practice (GMP) regulations.
  • Compliance Audits and Gap Analysis: Thorough compliance audits and gap analyses to identify areas where clients may fall short of FDA standards.
  • Risk Management and Mitigation: We help clients identify potential risks in their operations and develop strategies to mitigate these risks effectively.
  • Training and Education:  Comprehensive training programs on various aspects of FDA regulations and compliance best practices.
  • Documentation and Record-Keeping: Guidance on maintaining proper documentation and records, which are essential for demonstrating compliance.

At Riddle Compliance, we are committed to providing solutions that are not only compliant but also add value to our clients’ operations. We work closely with each client to understand their specific needs and challenges, offering tailored solutions that integrate seamlessly with their business processes. Partnering with Riddle Compliance means choosing a path toward enhanced compliance, operational efficiency, and continued success in the highly regulated healthcare industry.

extensive FDA compliance solutions and ad hoc assessments

  • Gap Analysis and Compliance Strategy Planning: Gap analyses to identify areas of non-compliance.
  • Mock FDA Audits and Inspections: Simulated audits provide a realistic assessment of your readiness for FDA inspections.
  • Form 483 Responses and Warning Letter Responses: Detailed and effective responses to FDA observations and warnings.
  • FDA Applications/Submissions Assistance: Expert guidance on FDA application processes.
  • Standard Operating Procedure (SOP) Development: SOPs to ensure consistent compliance and operational efficiency.
  • FDA Compliance Master Plans: Comprehensive FDA master plans for long-term compliance.
  • Project Management and Oversight: Robust project management solutions, complete with metrics and oversight to ensure project success.
  • Corrective and Preventive Actions (CAPA):  Developing and implementing effective CAPA to address compliance issues.
  • FDA Complaints and Recall Management: Management of FDA complaints and managing product recalls effectively.
  • Medical Device Reporting (MDR) and Serious/Adverse Event Reporting (S/AER): Expert assistance in fulfilling reporting obligations for medical devices.
  • Comprehensive Training Programs: Tailored training sessions on various FDA requirements.
  • Document, Change, and Design Controls: Guidance on maintaining proper documentation, managing change controls, and adhering to design controls.
  • Production and Process Controls, Including HACCP: Production and process controls, as well as Hazard Analysis and Critical Control Points (HACCP).
  • FDA Regulatory Training and Legal Support: Specialized training on FDA laws and regulations to support compliance.
  • Website and Labeling Review: Product labeling and website content are compliant with FDA regulations.

Riddle Compliance extends its FDA consulting services across a wide range of industries regulated by the FDA, including medical devices, dietary supplements, tobacco, drugs/pharmaceuticals, biotechnology, and food production. Our goal is to ensure that your operations are not just compliant, but also streamlined and efficient.

key considerations and questions for prospective clients regarding FDA compliance

  • How well does your organization understand the current FDA regulations relevant to your industry?
  • Do you have a comprehensive compliance strategy in place to adhere to FDA regulations?
  • How prepared is your organization for FDA inspections and audits?
  • Have you conducted mock audits to assess readiness?
  • Do you have an effective plan to respond to FDA Form 483 observations or Warning Letters?
  • How robust are your Quality Management Systems (QMS) in meeting FDA Good Manufacturing Practices (GMP) requirements?
  • Are your employees adequately trained on FDA compliance requirements and the importance of adherence?
  • Is your product labeling and marketing material in compliance with FDA regulations?
  • How effectively does your organization manage documentation and records to ensure they meet FDA standards?

For more detailed information on our FDA consulting services or to schedule a comprehensive consultation, please contact Riddle Compliance. Partner with us to navigate the FDA regulatory landscape with confidence and precision.