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
PharmEng Technology (PE) Group
Our RA Services
We provide on-site and remote regulatory support & regulatory outsourcing solutions :
Regulatory Strategy & Product Life Cycle Management
Pre-Market Authorization Application and Management
Pharmacovigilance, Post-Market Surveillance and Compliance
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.
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.