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PharmEng Global

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Asia Pacifico

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

Regulatory Intelligence Consultation and Advisory

Strategic due diligence before market expansion planning
See All Services > Regulatory Affairs > Regulatory Intelligence Consultation and Advisory

Our pre-market entry strategy involves much of regulatory intelligence and advisory services provided by our RA consultants, assisting clients who may need vital information for the preparation of a successful dossier, or just to understand the regulatory nuances of the countries of interest. With a decade long experience and local consultants in various countries to offer support in native languages across various product categories, PharmEng breaks cultural barriers to offer a big picture of the regulatory landscape to complete product registration. Such initial regulatory intelligence saves high level executives much precious time to plan their overall strategy for market access.

Services

  • Expert advice on Regulatory Strategy
  • Marketing Authorization Requirements
  • Product classification assessment
  • Registration Pathway, Procedures
  • Approval Timeline and Fees
  • Regulations and compliance requirements
  • Preclinical, clinical and CMC requirements
  • Documentary and Test requirements
  • Due Diligence, Risk and Gap Analysis
  • Product lifecycle planning
  • GMP and GDP requirements
  • Quality Management Systems
  • Quality Assurance
  • Pricing and reimbursement policies

Countries

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