Vaccines and Biologics

Protect. Heal. Innovate.

Advancing Health Together

Gardner Law provides expertise to companies on regulatory compliance, licensing agreements and FDA approval assistance as it relates to vaccine and biologic products. We offer expertise in compliance review and assists in drafting contracts with suppliers, manufacturers, payors, PBMs, and vendors.

Representative Matters Include:

  • PHSA Section 361 and 21 CFR 1271 analyses
  • Regulatory assessments and opinions on device classification and regulatory pathways
  • Strategy and preparation for FDA meetings and communications
  • Research and clinical study support, including drafting and negotiating Clinical Trial Agreements, subject recruitment practices
  • State manufacturing licensing
  • Compliance policies and procedures
  • Setting up a compliance program
  • Speaker Bureaus
  • Compliance audits, investigations, and training
  • Reviewing website and mobile apps, terms of use
  • Privacy and cybersecurity audits
  • Privacy and cybersecurity policies and procedures
  • Privacy and security incidents
  • Privacy officer and data protection officer services
  • Privacy training for organizations, including case coverage and complaint handling
  • FDA Quality Management System requirements, risk management, design controls, complaint handling, CAPAs
  • Recalls, corrections, and removals
  • Litigation and enforcement actions
  • Product liability strategy and counseling
  • Advertising and promotional review
  • Due diligence review for FDA-regulated companies
  • Transparency reporting to federal (“Sunshine Act”), state, and municipal authorities
  • Counseling on patient support programs