• Regulatory Services in Sri Lanka

    Overview

    Aiming at diversification of medicinal products and medical devices manufacturing base, Sri Lanka offers good business opportunities for Pharma, Biogen and Generic product manufacturers. For the market entry, however, the new entrants are obliged to obtain approvals from Cosmetics, Devices, & Drug Regulatory Authority (CDDA). Only drugs/devices registered and compliant with the authority standards can be manufactured, imported and marketed for sale in the region.

  • Regulatory Services in Pakistan

    Overview

    With a developing Pharmaceutical market that boasts a good fortune for foreign medicinal product and medical device manufacturers, Pakistan attracts significant investments in the region. To access the market, manufactures must obtain approvals from the Drug Regulatory Authority of Pakistan (DRAP), a regional health authority that regulates the manufacture, import, export, storage, distribution and sale of therapeutic goods.

  • Regulatory Services in Cambodia

    Overview

    The rapid economic growth coupled with domination of imported pharmaceuticals makes Cambodia a lucrative destination for foreign medicine and medical device manufacturers to invest in the region. The Ministry of Health, Cambodia and Department of Drugs and Food (DDF) oversees the drug regulations and registrations in the region. However, to navigate the Cambodian Regulatory regime manufacturers require expert Regulatory affairs for successful compliance and timely market authorizations.

  • Regulatory Services in Philippines

    Overview

    Emphasizing the growth prospects of life sciences industry coupled with good number of foreign investments in pharmaceutical companies, Philippines offers credible growth opportunities for foreign medicinal and medical devices manufacturers. The FDA (Food and Drug Administration) Philippines, oversees the registrations and regulations in the region. Though the market boasts better monetary gains, the stringent Regulatory framework in the region might challenge manufacturers’ compliance efforts for healthy authority approvals and market authorizations. 

  • Regulatory Services in Taiwan

    Overview

    With an extremely diverse business opportunities, Taiwan boasts a beneficial investment scenario for foreign medicine and medical device manufacturers. Taiwan Food and Drug Administration (TFDA) under the guidance of Department of Health (DOH) oversees the regulatory activities in the region. Though the region seems to be lucrative, constantly evolving Regulatory landscape might challenge the manufacturers with region-specific Regulatory obligations.

  • Regulatory Services in Bangladesh

    Overview

    With its significant socio-economic developments in recent years, and being well-known for technologically advanced pharmaceutical sector, Bangladesh offers deserved growth opportunities for foreign Medical Device / Medicinal product manufacturers who are willing to enter the region. Under the Ministry of Health & Welfare, Drug Control Committee (DCC), and the Director General of Drug Administration of Bangladesh (DGDA) supervises the drug regulations in the country.

  • Regulatory Services in India

    Overview

    Rapid urbanization, increased consumer spending and projected growth rates signifies a better scope for foreign medicine or medical device manufacturers who are willing to enter the Indian subcontinent. India’s regulatory regime for pharmaceuticals and medical devices is regulated by the Central Drug Standards Control Organization (CDSCO).