CenPharma
Compliance.
Engineering.
Innovation.
Your Partner in Pharmaceutical Compliance
At CenPharma, we specialize in providing comprehensive compliance and quality consulting services tailored for the pharmaceutical industry. From the early stages of clinical development to the complexities of commercial operations, our expertise spans all dosage forms.
Trust us to guide you through every phase of your pharmaceutical journey with precision and professionalism.
Here's why:
Comprehensive QMS Development
CenPharma LLC specializes in creating robust Quality Management Systems tailored to the unique needs of pharmaceutical companies, ensuring compliance and operational excellence from clinical trials to commercial production.
Inspection Readiness Support
CenPharma has the expertise to guide your team in building strategies to meet challenges of PAI and general GMP audits by regulatory agencies across the globe. Our inspection readiness team can support you in staff training, storyboard development, logistics planning, and mock inspections.
Compliance Remediation Support
CenPharma can help guide your organization through the stress created by regulatory observations. Our team has a proven tool kit for audit response, workstream creation, and remediation project management that can be tailored for support ranging from minor audit findings to consent decree response.
Data Integrity Center of Excellence
CenPharma experts understand the criticality of data integrity in all aspects of our industry. Firms can rely on our teams to provide assessments into their data generation, management, and archival practices across the site, as well as support in addressing identified risks of non-compliance with ALCOA+.
Qualification and Validation
CenPharma technical experts can guide your teams through tailored solutions for all your validation program challenges ranging from basic equipment qualification to complex process flows requiring unique protocols and methodologies, including new computerized system validation to align with the current regulatory landscape.
Interim Leadership and Staff Support
CenPharma staff have the background and knowledge to provide interim leadership to firms of any size within their Quality or Validation organizations. Our team members are prepared to be a part of your team and support you in meeting your goals.
Let us be your solution
Who we help
Large Pharmaceutical Firms
CenPharma assists large pharma firms with: - Interim senior quality leadership - Staff augmentation - Commissioning and qualification activities - Auditing - General documentation needs (review, metrics, document control) - Cleaning and Process Validation - Internal Auditing - Data Integrity Assessments - Compliance Remediation
Startup to Midsize firms
CenPharma assists startup to midsize firms with - Establishment of quality managment systems - Management of quality management systems - Interim senior quality leadership - Inspection readiness - Audit logistics - Supplier qualification - Internal auditing - External auditing - Commissioning and Qualification - Cleaning and Process Validation - Data Integrity Asessments - Compliance remediation
503B Compounding Pharmacies
With our deep expertise in GMP regulations at all phases of development, clinical trials and commercialization, CenPharma is well-positioned to assist 503B compounding pharmacies with their GMP needs. CenPharma has assisted current 503B firms with all manner of GMP activities including: - QMS development and management - EM requirements - Analytical Requirements - Inspection Readiness - Auditing - Supplier Qualification
Analytical Laboratories
CenPharma works with analytical labs, R&D labs and Quality Control labs to ensure clients are selecting the best technology and systems to support a cutting edge and compliant laboratory. Services include: - Tailored analytical development services - Validating methods - Overseeing method transfers - Streamlining analytical development - Accelerate product timelines - Design and setup of cutting-edge laboratories for upgrade or expansion
Our partners
...and counting!
Meet our team
Diane Gates
President
Diane is a proven Quality professional with over 20 years experience in the pharmaceutical industry. She has extensive knowledge of Quality Assurance, Compliance Remediation, Inspection Readiness/Auditing, Equipment, Process, Cleaning, and Automation Validation.
Kairo Jewell
Business Developer and IT Specialist
Kairo is an experienced sales professional, a certified System Administrator, and a freelance Game Developer. He is an expert in Client Relationships, Business Efficiency, and Customer Satisfaction. He also has extensive knowledge of system networking, computer programming, and automation.
At CenPharma, we are dedicated to leveraging our expertise to help our clients meet their overall compliance objectives in support of their development and production goals. Our success in mirrored in the success of our clients providing meaningful medications to patients in need.