Projects

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

Region Wide Submissions for First Biosimilar Drug

 

Client: 

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

 

Client: 

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

 

Testimonial: 

"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 All RANs Backlog have also been successfully completed, with RAN issues remediated and all withdrawn issues resolved.", Pfizer Indonesia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

 

Client: 

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.

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Regulatory Analysis and Technical Writing

 

Client: 

Various information publishers (2003 to date)

 

Nature of work: 

Regulatory analysis, comparison and technical-writing

 

Area of work: 

East and Southeast Asia.

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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
  • ...