cGMP Compliance Consulting Services, Audits & Training

Achieve cGMP Compliance & Quality Excellence in Biotech & Pharma

Navigate the complex regulatory landscape with Pace® GMP consulting services. We provide expert support in achieving and maintaining cGMP compliance, ensuring the successful development and commercialization of drugs, biologics, devices, and combination products.

Meeting FDA and EU standards, including the critical EU Annex 1 for sterile manufacturing, is paramount. Don't fall further behind – partner with us today!

Your Partner in cGMP Compliance and Quality Assurance

Whether you're a burgeoning biotech startup or an established pharmaceutical organization with specific project needs, Pace® offers the knowledgeable support you require for robust quality management systems. We take the time to understand your unique business, project workflows, and methodologies to deliver tailored solutions.

Key GMP Consulting Services Offered

  • GMP Audits

  • GMP Compliance

  • GMP Quality Assurance

  • GMP Quality Management Consulting

  • GMP Risk Management

  • GMP Validation

  • GMP Training

  • QMS Development

  • Gap Assessments

  • Regulatory Inspection Readiness

  • Batch Record Review

  • Contamination Control

  • Environmental Monitoring Programs

Our experts have over 25 years of industry experience, enabling us to meet you where you are at in the compliance process. Whether you need to perform an internal audit to prepare for regulators, or pursue supplier or vendor audits, we partner with your best interests in mind. 

Whether you need help addressing a backlog or remediating audit/483 observations, our experts help resolve outstanding compliance issues. 

Meeting Stringent Regulatory Standards, Including EU Annex 1

Our experienced consultants possess a deep understanding of the current regulatory landscape, including the critical requirements of EU Annex 1 for sterile manufacturing. We provide effective risk management recommendations and implement strategies to ensure successful cGMP compliance with both FDA and EU standards.

Don’t delay – ensure your operations are on track.

Our Approach: Tailored Solutions for Your Success

At Pace®, we prioritize understanding your specific business objectives, project goals, and existing methodologies. Our talented personnel apply their technical skills, professional demeanor, and meticulous attention to detail to deliver practical and effective validation, regulatory, and compliance outcomes for your needs and beyond. We are your trusted Good Manufacturing Practice consultants offering cost-effective, budget-friendly partnership opportunities.

Ready to Ensure cGMP Compliance and Quality? 

Contact us today to discuss your specific needs and challenges. Our team is ready to provide the expert guidance and support you need to achieve and maintain the highest standards of quality and regulatory compliance.

Reach An Expert