Our Support at a Glance...

Diagram below shows an overview of the regulatory services we provide, incorporating regulatory strategies and product life cycle management for market access approval to different parts of Asia and rest of the world.

Regulatory Strategy & Product Life Cycle Management
Strategic Regulatory Access to Markets

 

            We provide:
 
  • On-site and remote regulatory consulting & support
 
  • Technical staff outsourcing
 
Product Classification
 
  • NCE / NDA

  • Generics

  • Biologics

  • Biosimilars

  • Orphan Drugs

  • Veterinary Medicines

  • Medical Devices, ​

  • Advanced Drug-

  • Device Combination Products

  • Cosmetics

  • Health Supplements

  • Food

  • TCM

Regulatory Intelligence
 
  • Expert advice on regulatory strategy

  • Product lifecycle planning

  • Risk and gap analysis

  • GMP and GDP requirements

  • Product classification assessment

  • Regulations and compliance requirements

  • Quality Management Systems

  • Quality Assurance

  • Preclinical, clinical data and dossier requirements

  • Approval pathways and lead time

  • Registration fee

  • Pricing and reimbursement policies

Pre-market Submission
 
  • Project Management

  • Engagement of subject matter experts

  • Module 1 Application

  • eCTD / ACTD conversion, preparation and submission

  • Country specific dossier and labeling translation, compliance review and assembly

  • Master files compliance evaluation

  • CMC review

  • Submission filing to local regulatory agencies

  • Regulatory agency meetings and feedback

  • Reimbursement application

  • GMP and GDP audit inspections

Post-market Compliance
 
  • Post-market Surveillance and Pharmacovigilance

  • Periodic Safety Update Reports (PSUR)

  • Adverse event reporting

  • Variation submission

  • Gap analysis and remediation

  • Renewal applications

 

Market Access

 

  • Marketing Authorization Holder Application

  • Establishment Registration

  • Manufacturer Site Inspection

  • Import License Application

  • In and out licensing

  • Transfer of license

  • Product License holding and protection

  • Technology Transfer

Join Our Mailing List

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

Get connected with us!

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

USA 

+1 770-753-6032

 CANADA
+1 416-385-3922

 GREATER CHINA

+86 139 10489545

SOUTHEAST ASIA

+65 68365524

All rights reserved by PharmEng Regulatory Affairs. Disclaimer

Malaysia.png

Describe your image here