(919) 949-4617 nchew@ranainc.com

Our Experience

We have behind us a trail of satisfied clients who have given us assignments in the following areas.

FDA Liaison

  • Plan, rehearse and attend FDA meetings
  • Act as US agent for FDA matters
  • Integrate regulatory strategy into research and development programs

General Regulatory Consulting

  • Advise on European and US registration strategies
  • Integrate regulatory strategic planning into product development programs
  • Audits and Quality Assurance Services
  • Liaison with the FDA
  • Plan submissions
  • Annual Reporting

Audits and Quality/Assurance Services

  • Quality assurance systems and audits
  • Monitor ongoing studies
  • Good manufacturing practice audits
  • Pre-approval Inspection Readiness
  • Pre-submission audit and review
  • Design and monitor validation studies

Product Development Consulting

  • Integrate regulatory strategy into research and development programs
  • Evaluate product candidates for licensing
  • Identify and qualify contract research vendors
  • Negotiations with FDA

Submissions and Dossier Development

  • Advise on European and US registration strategies
  • Coordinate multiple submissions for products developed simultaneously in Europe and North America
  • Electronic submissions
  • Establishment license applications
  • Establishment Registrations
  • Investigational new drug applications and amendments
  • Investigator’s brochures
  • New drug applications and supplements
  • Orphan products applications
  • Package inserts, including annotation
  • Plan submissions
  • Product Listings
  • Summary bases of approval

Expert Witness

  • Consulting services during preparation and discovery
  • Expert Reports
  • Testimony

Get in touch today

Envision yourself expertly supported for a comfortable successful experience navigating the labyrinth of procedures, forms, and requirements and call us today to know more and get started.