Business Details
29 Years
experience
Your Trusted Partner for Life Science Consulting Solutions
PharmEng Technology, part of the Efor Group, has been a trusted leader in life sciences consulting since 1997. Our global team of over 3,000 experts delivers innovative solutions across pharmaceutical, biotechnology, and medical device industries. With deep expertise in validation, regulatory affairs, quality systems, and engineering, we ensure compliance with international standards while driving cost-effective, high-quality outcomes.Our multicultural team combines local market knowledge with global best practices, supported by offices in 12 countries. We prioritize client partnerships, leveraging decades of experience to address complex challenges in drug development, manufacturing, and regulatory compliance. Our commitment to excellence is reflected in our proven track record of successful projects and adherence to rigorous quality assurance frameworks.
Services
Automation Engineering
Commissioning Qualification
Process Validation
Regulatory Submissions
Quality Auditing
Thermal Mapping
Toxicology Risk Assessment
GMP Training
Project Management
Technical Writing
Details
- Year established: 1997
Highlights and features
- We offer 28+ years of specialized expertise in life sciences consulting.
- Our global team operates in 12 countries with local regulatory knowledge.
- We implement risk-based approaches for data integrity and compliance.
- Our ASQ-certified auditors ensure adherence to FDA, EMA, and ISO standards.
- We provide end-to-end solutions from drug discovery to post-market compliance.
Associations and certifications
- American Society for Quality (ASQ)
- Regulatory Affairs Certification (RAC)
- Project Management Professional (PMP)
What people say
Proven expertise
Regulatory compliance
Global reach
Technical depth
Project delivery
Services
Regulatory Affairs
Our RAC-certified consultants specialize in global regulatory submissions for pharmaceuticals and medical devices. We provide end-to-end support including dossier preparation, label review, and agency interactions. With expertise in FDA, EMA, and ASEAN regulations, we help clients achieve product approvals while maintaining compliance with evolving international standards.
Process Validation
We offer comprehensive validation services for pharmaceutical manufacturing processes. Our team develops protocols incorporating critical quality attributes and performs statistical analysis to ensure consistent product quality. Services include process capability assessments, cleaning validation, and analytical method validation aligned with FDA guidelines and ICH Q2 standards.
Quality Auditing
ASQ-certified auditors conduct GMP compliance assessments and supplier audits across pharmaceutical, biotech, and medical device sectors. We perform gap analyses, remediation planning, and regulatory inspection readiness assessments while maintaining compliance with FDA, MHRA, and Health Canada requirements.
Thermal Mapping
Our experts perform thermal process validation for sterilization, storage, and transportation systems. Services include temperature/humidity mapping, autoclave qualification, and cold chain validation using calibrated data loggers to ensure compliance with USP and EU GMP Annex 11 requirements.
Toxicology Risk Assessment
Board-certified toxicologists conduct risk assessments for active pharmaceutical ingredients and excipients. We provide extractables/leachables evaluations, cleaning validation limits, and health-based exposure assessments to ensure patient safety while meeting regulatory expectations for cross-contamination control.
People
Alan Kwong
Founder, CEO & Managing Director
Chemical engineer with 30+ years pharmaceutical industry experience. Founded PharmEng in 1997 after leadership roles at Purdue Pharma and Glaxo. Holds B.Sc. from University of Michigan and MBA from University of Toronto.
Dr. Wendy Haines
Director of Toxicology & Quality Services
Board-certified toxicologist with 25+ years experience in pharmaceutical safety assessments. Conducted over 350 risk assessments and specializes in extractables/leachables evaluation and cleaning validation toxicology.
Bruce Craven
Executive VP & Managing Director, Americas & Europe
25+ years pharmaceutical QA and validation leadership. Former executive roles at major engineering firms. Active ISPE and PDA member with expertise in compliance strategy and business development.
Yee Ju Chen
Director, Asia
15+ years regulatory affairs experience in Asia-Pacific markets. Specializes in medical device registrations and market entry strategies for pharmaceutical companies seeking regional expansion.
Dr. Nizamil Fairuz Yahya
Director, Malaysia
20+ years pharmaceutical engineering experience across North America and Southeast Asia. Expert in GMP plant start-ups and regulatory compliance with focus on ASEAN market requirements.
Questions
What industries does PharmEng Technology serve?
We specialize in pharmaceutical, biotechnology, medical device, and nutraceutical industries with tailored consulting solutions.
Do you offer international regulatory support?
Yes, our RAC-certified consultants provide regulatory submissions and compliance support across North America, Europe, and Asia-Pacific markets.
What validation services are available?
We offer process validation, cleaning validation, computer system validation, and analytical method validation services aligned with FDA and ICH guidelines.
Can you assist with GMP training programs?
Yes, we develop customized GMP training programs including live webinars, workshops, and on-the-job training tailored to client needs.
Do you provide on-site consulting services?
Yes, our consultants provide on-site support for validation, audits, and compliance projects at client facilities worldwide.
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