The following sample projects illustrate the nature and country coverage of projects we have worked on.

Region Wide Submissions for First Biosimilar Drug



Asian biosimilar developer and manufacturer (2013 - ongoing)


Nature of work: 

Pre-market submission, advisory and regulatory liaison


Area of work: 

Singapore, Malaysia, Philippines, Thailand, Vietnam


Region Wide Compliance Work for Major Pharmaceutical Company



Pfizer (2013 - ongoing)


Nature of work: 

Post-market files reconciliation and compliance review for both local-market and global-market compliance


Area of work: 

Singapore, Malaysia, Brunei, Indonesia, Philippines, Thailand, Vietnam, Myanmar, Cambodia, Hong Kong, Macau, China, Taiwan



"PharmEng RA completed the RAN project on time. All RANs Backlog have also been successfully completed, with RAN issues remediated and all withdrawn issues resolved.", Pfizer Indonesia

MAH Work for Innovative Biological Injectible



Western specialty developer and manufacturer (2013 - ongoing)


Nature of work:

Pre-market submission of innovative biological product, with MAH appointment planned after successful pre-market submission.


Area of work: 

Malaysia, with expansion to Singapore planned.




Regulatory Analysis and Technical Writing



Various information publishers (2003 to date)


Nature of work: 

Regulatory analysis, comparison and technical-writing


Area of work: 

East and Southeast Asia.


Our RA Client List

We have assisted the below clients and others in various regulatory services, such as strategic intelligence, advisory and research, technical writing, region wide dossier formatting, compliance, product registration, commercial strategy etc, as on-site contract consultant and off-site virtual RA support:

  • Abbott
  • Accord Healthcare
  • Allergan
  • Amgen
  • Apotex
  • Arriello
  • Baxter
  • Biogen
  • Biomarin
  • BioProduct Labs
  • Cadila Healthcare
  • Capsule Pharma
  • Cepheid
  • Celltrion
  • Chantecaille Beaute
  • Circle Cardiovascular
  • Ekso Bionics
  • EverPharma
  • Farmavita R
  • Fidia Farmaceutici
  • Gepact Pharmallink
  • Genzyme
  • GSK
  • Hikma
  • Innokeys
  • Johnson & Johnson
  • LaCorium Health
  • Link Healthcare
  • Market America
  • MatrixStar Marketing
  • Meditip
  • MediqTrans
  • Milani
  • Naari
  • Nestle
  • Nuron Biotech
  • Ocean 27
  • Pfizer
  • Pro.Med.CS. Praha
  • Qalian
  • Ramblin Brands
  • Reckitt Benckiser
  • Roche
  • Roquette
  • SAM Sérélys Pharma
  • SERI
  • SGS
  • Sidrapex
  • SOS Group
  • Swiss Global Enterprise
    ST Logistics
  • Tarius
  • Techpool BIo-pharma
  • Tee Hai Chem
  • Tembusu Healthcare
  • ThermoFisher Scientific
  • Thomson Reuters/Clarivate
  • Unipharm
  • Upjohn & Pharma
  • Vifor Pharma
  • Wyeth
  • Yangtze River Pharmaceutical
  • Zydus
  • ...

Join Our Mailing List

Keep in touch with us by joining our mailing list or follow our company page at LinkedIn


+65 68365524


+86 139 10489545

+1 416-385-3922


+1 919-474-8309

Get connected with us!

Any questions for us? Feel free to let us know.

All rights reserved by PharmEng Regulatory Affairs. Disclaimer