Our Specialties

We provide specialized regulatory knowledge.

LRA Consulting is a full-service product development and regulatory consulting firm providing services tailored for each client. Our team has successfully managed product submissions in several areas, including cardiology, surgical instruments, orthopaedics, anesthesia, endoscopy, MRI’s, and intraocular lenses to name a few. We provide services from design concept through market approval, launch, and post-market reporting. Compliance requirements vary around the world; we provide and help execute customized strategies designed to guarantee timely and cost-efficient global product development. Some of the services we offer are:

Product development and strategy

  • Product development planning and design
  • Regulatory research
  • Determination of the best markets for the device
  • Short-term and long-term regulatory strategies for various markets

EU MDD to MDR gap analysis

  • Technical documentation
  • Labeling
  • Quality
  • PMS plan

Preparation of compliant technical documentation in global markets

  • 510(k), PMA, IDE, IND, NDA, EUA submissions to US FDA
  • Technical documentation submission to EU NB and Competent Authorities¬†
  • Product submissions to Latin American countries (Brazil ANVISA, Colombia INVIMA, Mexico COFEPRIS, Peru DIGEMID, Venezuela OICEM, Ecuador NHTM, Argentina ANMAT)
  • Product submissions to Asian countries (Japan PDMA, Taiwan TFDA, Thailand TFDA, China CFDA), Hong Kong DOH)
  • Product submissions to Health Canada
  • Product Submissions to Australia TGA

Assistance with regulatory body communication 

  • FDA Q-sub preparation and engagement
  • Selection and engagement with NB’s
  • Responses to questions, deficiencies and concerns

Quality systems

  • QS documentation development
  • GMP/GLP compliance
  • Audit preparation 
  • GMP/GLP and CAPA remediation strategies

Clinical Affairs

  • Study coordination
  • Protocol development

ISO 10993 Biological Evaluations

  • Biocompatibility assessments
  • Risk assessments
  • Chemical characterization protocol development