Jurisdictions & Regulatory Frameworks

Support across 12 major regulatory markets.

IntelaSolve^™ supports Life Sciences teams in organizing Quality, regulatory, clinical, technical documentation, and post-market evidence in alignment with leading global authorities and frameworks.

• United States

  FDA

  US

  Title 21 CFR, cGMP, GxP, QMSR, MDSAP where applicable

• Canada

  Health Canada

  CA

  Food and Drugs Act, Medical Devices Regulations, GMP, GxP, MDSAP

• United Kingdom

  MHRA

  UK

  UK medicines and medical device regulations, GxP, UKCA

• European Union

  European Commission, EMA, national competent authorities

  EU

  EU MDR, EU IVDR, EU pharmaceutical legislation, GxP, CE Marking

• Brazil

  ANVISA

  BR

  Brazilian health regulatory framework, GMP, GxP, MDSAP where applicable

• Japan

  MHLW / PMDA

  JP

  PMD Act, Japanese QMS and GxP expectations, MDSAP where applicable

• Australia

  TGA

  AU

  Therapeutic Goods framework, GMP, GxP, ARTG, MDSAP where applicable

• South Korea

  MFDS

  KR

  Korean Life Sciences regulatory framework, KGMP, GxP

• Singapore

  HSA

  SG

  Health Products Act, medical device and therapeutic product framework, GxP, MDSAP observer

• Switzerland

  Swissmedic

  CH

  Therapeutic Products Act, Swiss medical device and IVD ordinances, GMP, GxP

• Mexico

  COFEPRIS

  MX

  Mexican health regulatory framework, GMP, GxP, MDSAP affiliate

• Taiwan

  TFDA

  TW

  Taiwanese Life Sciences regulatory framework, GMP, GxP, MDSAP affiliate

IntelaSolve^™ supports alignment with these frameworks. Specific submission pathways and product-class requirements are addressed within each engagement.