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