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Transforming Science into Commercial Success

FDA Regulatory Compliance

Health Connexions and FDASmart Join in a Partnership to help Emerging Science Accelerate Success with US FDA Regulatory Compliance and Registrations

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FDASmart aims to help companies all over the world succeed in the US market. Often, foreign businesses do not succeed, not because of a lack of quality in their product, but because they do not meet US FDA regulatory compliance requirements.

Health Connexions, with a mission to help organizations transform science into commercial success, has recognized this significant gap holding back emerging science when it has been developed in other countries from around the world. Therefore, we have partnered with FDASmart help our clients have a fighting chance to succeed in the US market.

FDASmart provides a number of services to support US FDA regulatory compliance and registrations:

  • On-site GMP audits and assessments, as well as remote, virtual cGMP audits with the SmartInspect technology and service
  • Market intelligence and business development
  • US FDA registrations and submissions for NDA, ANDA, DMFs and medical device applications and the required submissions to meet US FDA regulatory compliance
  • Mobile healthcare application development; guidance as it relates to following the US FDA regulatory compliance guidelines
  • Forming collaborations for SMEs (Subject Matter Experts) between emerging markets (BRIC) and/or emerging science from any country, and the US

FDASmart has helped many biotechnology and pharmaceutical companies expand and grow in the United States. Health Connexions is excited to launch this new partnership!