India and Southeast Asia
Best Regulatory Consulting Company in India
(Times Media’s 2013 Global Healthcare Excellence Awards)
With disappointing growth in developed markets, healthcare companies have been turning to the emerging Indian and ASEAN markets (Indonesia, Malaysia, the Philippines, Singapore, Thailand, Brunei, Burma, Cambodia, Laos, and Vietnam). Most major Pharmaceutical companies have accelerated efforts to strengthen their presence within these markets through R&D investment, licensing deals, acquisitions, and other forms of partnerships. Having in common to offer a huge untapped potential market, these regions display a wide diversity in regulatory frameworks and healthcare infrastructure. In terms of market size, India is comparable to the United States and is often considered by global Pharmaceutical manufacturers as a promising market. With a changing market demands and evolving regulatory landscape, devising successful strategies is a real challenge. Hence, tailor-made approaches are necessary to access each of these regional markets.
VCLS Indian team is located in Bangalore and acts as regional representative for foreign clients entering the Indian and to ASEAN markets.
- Opportunity assessment
- Identification and management of local partners (CRO, CMO, distributor)
- Audit of facilities
- Registration of drugs, biologics, medical devices and cosmetics in India and ASEAN markets
- Act as local representative for foreign companies
- Prepare and submit regulatory packages (e.g. Clinical Trial Applications, Marketing Authorizations)
- Support interactions with Drug Controller General of India (e.g. No Objection Certificate, New Drug Advisory Committee meetings) and ASEAN Authorities
- Import and export licenses
- Registration of manufacturing plants