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Asia Pacific

Singapore

Singapore

#03-20 Galaxis

1 Fusionopolis Place

Singapore, 138522

P: +65 68365524

Malaysia

Kuala Lumpur

Jland Biz Centre – Menara JCorp

No 249 Jalan Tun Razak

Kuala Lumpur, Malaysia 50400

P: +60 3 27872666

Indonesia

Jakarta

Ruko Citra Garden 6

Tegal Alur, Kalideres, Jakarta Barat

DKI Jakarta, Indonesia

P: +62 21 2789 9789

Taiwan

Taipei

11F-5, No. 91,

Hua Yin Street Taipei,

Taiwan 103

P:+886-2-55746135

Hong Kong

Hong Kong

8/F. Park Sun Building

No. 97-107 Wo Yi Hop Road

Kwai Chung, Hong Kong

P: +852 5801 0188

China

Hanghzou

866 Yuhangtang Road

Xihu District

Hangzhou, Zhejiang

P.R. China 310058

P: +8618989496483

Vietnam

Hanoi City

116c 2F Quang Trung Street

Tran Hung Dao Ward, Hoan Kiem

Hanoi City, Vietnam

Myanmar

Yangon

No. 520, Kabar Aye Pagoda Road

Rm. 206, Excel Tower

Bahan Township, Yangon

Myanmar

P:+65 68365524

North America

Canada

Toronto, ON

23 Lesmill Rd., Suite 410

Toronto, Ont. M3B 3P6

P: 416-385-3922

USA

Cary, NC

2500 Regency Parkway

Cary, NC 27518

P: 1-855-937-2497

USA

Atlanta, GA

200-2475 Northwinds Parkway

Alpharetta, GA 30009

P: 1-855-937-2497

Europe

Ireland

Cork, Ireland

The Cube Building,
Monahan Road,
Cork, Ireland.
T12 H1XY
P:+353 21 2376009

Spain

Barcelona, Spain

Av. Diagonal 409 1st floor

08008, Barcelona, Spain

P: (+34) 673 565 099

Latin America

Brazil

Pina, Recife

Av. Eng. Antonio de Goes, 60 Sala 702

Edf JCPM Trade Center 51.010-000

Tel: +55 81 4042 9049

Post-Market Compliance

Independent license holding representation for market access
See All Services > Regulatory Affairs > Post-Market Compliance

Acting as your virtual RA department, PharmEng utilizes a unique Market Access and Operational model that allows for independent license holding, authorizing distributors to import and supply. Acting as the MAH (Marketing Authorization Holder) or the PRH (Product Registrant Holder), we represent companies to register and hold product licenses without distributor risk or loss of brand control. In addition, companies also reduce the risk and expense of maintaining and managing its own RA department during the initial and marketing phase of market penetration, while undergoing product approval or manufacturing variation process and testing market feasibility.

Services

  • Post-market Surveillance and Pharmacovigilance
  • Periodic Safety Update Reports (PSUR)
  • Adverse event reporting
  • Field Safety Corrective Actions
  • Local Literature Screening
  • Life Cycle Variation submission
  • Change Notifications
  • Renewal applications
  • GMP Clearance
  • Manufacturing Site Transfers
  • Technology Transfer
  • Internal Audit support
  • Conformity Assessment Audits
  • Import & Wholesale License Application
  • Quality System Management

 

Countries

  • ASEAN: Singapore, Malaysia, Vietnam, Philippines, Myanmar, Cambodia
  • Asia Pacific: Taiwan, Hong Kong, China, Korea, Australia, New Zealand, India, Bangladesh