PharmEng Technology offers a comprehensive range of Quality Services to meet customer expectations, regulatory requirements, and ensure quality products are provided to the global market.
Six Sigma
Deviation & CAPA Management
Manufacturing Sciences
Quality Assurance
Quality Auditing
GxP Training
Data Integrity
Regulatory Affairs
PharmEng Technology has a unique staff base that includes Lean Six Sigma practitioners, American Society for Quality (ASQ) Certified Quality Auditors (CQAs), ASQ Certified Quality Engineer (CQEs), and an ASQ Fellow. We look forward to the opportunity to collaborate with you to provide quality support ranging from building a quality management system (QMS) to addressing compliance challenges within your organization.
Quality Assurance
PharmEng Technology’s Quality Analyses services division offers a comprehensive solution for design and implementation of QMSs, establishing key performance indicators (KPIs), and developing a comprehensive documentation system. Performing gap analyses and compliance assessments to identify areas of improvement to ensure clients’ QMSs comply with industry standards and regulatory requirements is a core competency. Remediation, corrective and preventative action (CAPA), deviation, out-of-specification (OOS) and root cause analysis (RCA) using a risk-based approach, tech transfer support, annual product quality review, validation and change management are among some of the areas of expertise.
Quality Auditing
PharmEng Technology consultants include American Society for Quality (ASQ) certified quality auditors with extensive experience in EMA, GMP, FDA, MHRA, Health Canada and other international regulatory guidelines. They understand the impact that continuous compliance oversight has on maintaining a QMS and have the expertise in performing internal/external quality system, supplier/vendor qualifications, and medical device audits. Our ASQ-certified auditors have conducted audits for both contract manufacturers and owner companies in the pharmaceutical, biotechnology, medical device, and personal care products industries.
GxP Training
PharmEng Technology works alongside clients to build customized training programs and perform company-wide GMP trainings to meet regulatory expectations, and ensure compliance to industry standards. We host workshops, live and virtual webinars on relevant topics and On-The-Job (OJT) training programs based on client needs.
Data Integrity
PharmEng Technology can provide your organization with an overall Data Integrity governance program and find solutions for your existing computerized systems to ensure accuracy and completeness of data to reach the highest level of quality and risk management. Our services support all types of businesses from contract manufacturers, third party suppliers, manufacturing, laboratory, storage and distribution, and post market surveillance.
Regulatory Affairs
PharmEng Technology includes RAC-certified consultants who perform regulatory submissions as per country requirements in Asia Pacific, North America, or Europe by working closely with regulatory agencies to achieve product license approval. Our services range from regulatory classification of products, dossier preparation, label and artwork review, publishing and submission, medical writing, and regulatory submission review. Our RAC-certified consultants have carried out submissions for both drugs and medical devices, among other products.
Upcoming Speaking Engagements
McIntosh, M. “Bringing Pharmaceutical Quality Auditing into the Digital Age.” Annual Parenteral Drug Association Meeting, Long Beach, CA, March 26, 2024
Selected Abstract
McIntosh, M. “Remote Supplier Auditing: A Risk-Based Approach.” Professional poster at Parenteral Drug Association Annual Meeting. New Orleans, LA, USA. 2023.
Hussain, V. “CAPAs and Deviations: Do’s and Don’ts.” Professional poster at Parenteral Drug Association Annual Meeting. New Orleans, LA, USA. 2023.
Selected Past Speaking Engagements
Mahrukh, M. and McIntosh, M. “Audit and QMS Basics.” American Society for Quality, Quality in the Triangle. Raleigh, NC, USA. October 10, 2023.
Harter, S. “Effective CQV Utilizing Kneat.” American Society for Quality, Quality in the Triangle. Raleigh, NC, USA. October 10, 2023.
Huhyn, D. “QA Toolbox – The Essentials for Pharma QA.” American Society for Quality PHXCON, Phoenix, AZ, Nov 2023.
McIntosh, M. “Supplier Audits: Expectations, Performance, & Preparedness.” American Society for Quality BOSCON, Boston, MA, Nov 2023.