Regulatory Focus Areas

  • Domestic & International Registrations
  • CE Marking
  • EU MDR Upgrades
  • Regulatory Submissions (NDA, BLA, IND 510K, PMA’s, etc.)

  • Technical Files/Design Dossiers
  • Advertising & Promotions
  • Regulatory Labeling
  • Regulatory Strategists with Therapeutic Specialties

  • Publishing
  • CMC
  • Regulatory Information Management Systems

Why choose QVR for your regulatory needs?

Audit Specialization

QVR can provide a specialized audit based upon your company's needs including: vendor audit, regulatory, mock audit, decommissioning, and/or a risk strategy. All audits and assessments are conducted in accordance with the FDA’s Pre-Approval Inspection Program that address facility, product, and process concerns.

Focused Expertise

QVR can lead, assist, or even compliment a sponsor's approach to approvals and submissions for both U.S. and International markets (510(k), ANDAs, NDAs, BLAs, INDs, APR).

Complex Issues

Many sponsor companies look to us to help with complex issues related to CMC expertise and to lead or support filings of developmental or approved products. QVR has also supported efforts with specific expertise around product labeling requirements.

Delivery Models

Project Staffing

SHORT AND LONG-TERM CONSULTANTS.

We provide talent to supplement your team, and support your organization’s research and rescue projects.

Life Sciences Recruiting

CONTRACT-TO-HIRE AND DIRECT HIRE RECRUITING.

QVR will shorten your search for top performing Life Sciences professionals and directly recruit from a pool of talent not readily available and accessible on job boards.

Project & FSP Solutions

CONSULTING AND OUTSOURCING.

QVR can provide project and FSP support for your organization within quality, regulatory, and validation functions.