Our Product

With help of our associates, we provide regulatory consulting services aligning with other countries as below

  • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH): Works on harmonising regulatory standards and guidelines internationally to facilitate the development and registration of pharmaceuticals across regions.

North America

  • United States Food and Drug Administration (FDA): Regulates drugs, biologics, and medical devices in the US. Oversees clinical trials, drug approval processes, and post-market surveillance.
  • Health Canada: Regulates pharmaceuticals, biologics, and medical devices in Canada. Oversees drug approvals, clinical trials, and market monitoring.

Europe

  • European Medicines Agency (EMA): Evaluates and supervises medicines for human and veterinary use in the EU. Coordinates the centralised marketing authorisation process and monitors drug safety.
  • Medicines and Healthcare products Regulatory Agency (MHRA): Regulates medicines, medical devices, and blood components for transfusion in the UK. Ensures compliance with safety, efficacy, and quality standards.

Asia-Pacific

  • Japan Pharmaceuticals and Medical Devices Agency (PMDA): Assesses drug and medical device applications in Japan. Provides guidance on regulatory requirements and monitors post-market safety.
  • National Medical Products Administration (NMPA): Regulates drugs, medical devices, and cosmetics in China. Oversees drug approval processes, clinical trials, and market surveillance.
  • Therapeutic Goods Administration (TGA): Regulates medicines, medical devices, and biological products in Australia. Ensures product safety, efficacy, and quality.
  • Korean Ministry of Food and Drug Safety (MFDS): Regulates food, drugs, and medical devices in South Korea. Ensures safety and efficacy through drug approval processes and post-market surveillance.
  • Singapore Health Sciences Authority (HSA): Regulates medicines, medical devices, and health products in Singapore. Oversees drug approvals, clinical trials, and market monitoring.

Latin America

  • Brazilian Health Regulatory Agency (ANVISA): Regulates pharmaceuticals, medical devices, and food products in Brazil. Manages drug approvals, clinical trials, and post-market surveillance.
  • Colombian National Institute for Food and Drug Surveillance (INVIMA): Regulates pharmaceuticals, medical devices, and food products in Colombia. Manages drug approvals, clinical trials, and market monitoring.
  • Argentinian National Administration of Drugs, Foods and Medical Devices (ANMAT): Regulates pharmaceuticals, medical devices, and food products in Argentina. Oversees drug approvals, clinical trials, and market monitoring

Middle East

  • Saudi Food and Drug Authority (SFDA): Regulates pharmaceuticals, medical devices, and food products in Saudi Arabia. Manages drug approvals, clinical trials, and ensures product safety and quality.
  • Gulf Cooperation Council (GCC) – Gulf Health Council: Coordinates regulation of pharmaceuticals and medical devices among GCC member states. Aims to harmonise regulations and improve healthcare standards across the region.

Africa

  • South African Health Products Regulatory Authority (SAHPRA): Regulates medicines, medical devices, and other health products in South Africa. Ensures product safety, efficacy, and quality.

South Asia

  • Indian Central Drugs Standard Control Organization (CDSCO): Regulates pharmaceuticals, medical devices, and cosmetics in India. Manages drug approvals, clinical trials, and post-market monitoring.
  • Indonesian National Agency of Drug and Food Control (BPOM): Regulates pharmaceuticals, medical devices, and food products in Indonesia. Oversees drug approvals, clinical trials, and market surveillance.
  • Philippine Food and Drug Administration (FDA Philippines): Regulates pharmaceuticals, medical devices, and food products in the Philippines. Ensures product safety, efficacy, and quality.

Taiwan

  • Taiwan Food and Drug Administration (TFDA): Regulates pharmaceuticals, medical devices, and food products in Taiwan. Ensures compliance with safety, efficacy, and quality standards.

Russia

  • Russian Federal Service for Surveillance in Healthcare (Roszdravnadzor): Regulates pharmaceuticals, medical devices, and healthcare services in Russia. Oversees drug approvals, clinical trials, and post-market surveillance.