Contact Us
PharmEng Global

Canada

Toronto, ON

23 Lesmill Rd, Suite 410

Toronto, ON M3B 3P6

Tel: 416-385-3922

USA

Durham, NC

1 TW Alexander Dr. Suite 125

Durham, NC 27703

P: 919-474-8309

USA

Atlanta, GA

200-2475 Northwinds Pkwy

Alpharetta, GA 30009

P: 1-855-937-2497

USA

Berkeley, CA

2001 Addison Street

Suite 300

Berkeley, CA 94704

P: 1-510-356-0788

Indonesia

Jakarta

Ruko Citra Garden 6

Tegal Alur, Kalideres, Jakarta Barat

DKI Jakarta, Indonesia

P: +62 21 2789 9789

Malaysia

Kuala Lumpur

1 Sentral, Level 16,
Jalan Stesen Sentral 5,
KL Sentral, Kuala Lumpur, 50470
Malaysia

Tel: +60 3 2787 9141

Singapore

Singapore

#03-20 Galaxis

1 Fusionopolis Place

Singapore, 138522

P: +65 68365524

Taiwan

Taipei

11F-5, No. 91,

Hua Yin Street Taipei,

Taiwan 103

P: +886-2-55746135

Denmark

Copenhagen

PharmEng Nordic ApS
Fredericiagade 15,
København, Denmark
1310
Phone: +45 9389 1976

Ireland

Cork

The Cube Building,
Monahan Road,
Cork, Ireland.
T12 H1XY
P: +353 21 2376009

Spain

Barcelona

Calle Rossello, NUM 224

Planta 4, Puerta C

Barcelona, 08008 Spain

P: (+34) 673 565 099

Puerto Rico

Puerto Rico

Caguas, Valle Tolima

INOVA Ave Innovación Lote 16,

Caguas, Valle Tolima, 00726

Tel: 787-344-1591

Brazil

Pina, Recife

Av. Eng. Antonio de Goes, 60 Sala 702

Edf JCPM Trade Center 51.010-000

Tel: +55 81 4042 9049

Dominican Republic

Santo Domingo

Av. Winston Churchill, Torre Citi Acropolis, Piso 8

Email: info@pharmeng.com

Tel: +1-809-731-8123

Quality Services

Our qualified consultants will partner with you to ensure all quality needs are met according to regulatory requirements and best practices.
> Quality Services

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.

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.

Six Sigma
Deviation & CAPA Management
Manufacturing Sciences
Quality Assurance
Quality Auditing
GxP Training
Data Integrity
Regulatory Affairs

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.

quality systems in pharmaceutical industry

PharmEng Technology offers a comprehensive range of Quality Management System (QMS) services to support various businesses and industries in meeting customer expectations, regulatory requirements, and staying competitive.

PharmEng Technology has a unique staff base to accommodate your quality needs. We look forward to the opportunity to collaborate with you to provide quality support ranging from building a QMS to addressing compliance challenges within your organization.

Quality Assurance
Quality Auditing
GxP Training
Data Integrity
Regulatory Affairs

Quality Assurance

PharmEng Technology’s Quality Assurance services division offers a comprehensive solution for design and implementation of QMS, establishing key performance indicators (KPIs), and developing a comprehensive documentation system. Gap analysis and compliance assessments identify areas of improvement to ensure clients’ QMS 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 of what continuous compliance oversight has on maintaining a QMS and 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. Regulatory Affairs

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.

Upcoming 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.

quality systems in pharmaceutical industry

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