PharmEng RA helps foreign companies with little or no presence in Asia, bring their products to market. We are engaged in technical and regulatory consultancy services region-wide in Asia, specializing in Asia Pacific regulatory affairs, and in branded, premium, proprietary products where quality and data confidentiality are critical.  

 

Our experience spans over a decade in Greater China, Southeast Asia, Australia and New Zealand, working out of offices in Singapore, Malaysia and Taiwan, supported by a network of local experts in all the major countries. 

 

With our strength in Regulatory Intelligence, we devise sound Regulatory Strategies to bring safe, efficacious and high quality products to market, using the shortest timeframe to support their product life cycle.

 

Our clients comprise many of the multinational developers and manufacturers of proprietary and innovative pharmaceutical and medical device products, and also key consulting companies who need registration and licensing support in Asia and beyond.

 

We provide full regulatory support from post-clinical to post-marketing, establishing close working relationships with our clients and the regulatory authorities to meet key milestones on time and on budget.

 

Our full spectrum of services includes pre-market submissions, representation work as Authorized Agents, Marketing Authorization Holders (MAH) and Product License Holders (PLH) in selected countries, as well as post-market variation and pharmacovigilance to ensure continued compliance of your product(s) in the face of changing local developments

 

 

PharmEng Regulatory Affairs (PharmEng RA)

 

The Lead Office for Regulatory Affairs Services 
for the
PharmEng Technology (PE) Group
 
Our RA Services

 

We provide on-site and remote regulatory support & regulatory outsourcing solutions :

 

  • Product Registration 

 

  • Regulatory Strategy & Product Life Cycle Management

 

  • Regulatory Intelligence

 

  • Pre-Market Authorization Application and Management

 

  • Pharmacovigilance, Post-Market Surveillance and Compliance

 

  • Post-Market Pharmacovigilance

  • Manufacturer & Licensing Representation 

Pre Market Submissions

 

PharmEng RA helps manufacturers obtain certification or approval to sell their medical devices and pharmaceutical products in Asia. Through our Asian offices, we can guide you through the language barriers and complex registration processes in China, Indonesia as well as other Southeast Asian countries.

Pharmacovigilance & Compliance

 

PharmEng RA leverages on its expert network and experience to assess your company’s compliance levels in Asia, from evaluating the risk of fines to exposure to theft and diversion. Our pharmacovigilance service also helps you adapt your safety monitoring and reporting practices in response to fast changing regulatory environments in Asia, allowing you to better manage risk and compliance cost your project lifetime.

Manufacturer Representation

 

PharmEng can represent manufacturers as their Marketing Authorization Holder (MAH) in various Asian countries. This has distinct advantages over a distributor MAH, as there will no problems associated with switching distributors.  In some countries, distributors may delay returning the product licenses and the transfer itself may include a substantial fee. Moreover, a MAH may need to know confidential information such as raw materials, product development / design specifications as part of the product registration process. An independent MAH such as PharmEng can help manufacturers avoid these problems, as the sustainability of our business relies on protecting our reputation in the marketplace.

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

SOUTHEAST ASIA

+65 68365524

 GREATER CHINA

+86 139 10489545

 CANADA
+1 416-385-3922

USA 

+1 770-753-6032

Get connected with us!

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

All rights reserved by PharmEng Regulatory Affairs. Disclaimer

USA.png

Describe your image here