Drug
Dynamic Doing
Advice to Action
Gardner Law provides comprehensive guidance and support to pharmaceutical firms, aiding them in understanding and adhering to pertinent laws, regulations, and standards. Our depth of real-world experience lets us help pharmaceutical companies go from advice to action. Gardner Law assists in drafting contracts with suppliers and manufacturers and advises on risk management and product development strategies. With practical experience in reimbursement, privacy and cybersecurity, compliance, state licensing, litigation, and regulatory matters, Gardner Law is uniquely equipped to address your most complex challenges and get you from thinking to doing.
Representative Matters Include:
- FDA regulatory strategy and submission support related to: Investigation New Drug (IND), 505(b)(2) New Drug Application (NDA), Abbreviated New Drug Application (ANDA)
- Regulatory assessments and opinions on product classifications and working with the FDA Office of Combination Products (OCP)
- Strategy and preparation for FDA meetings and communications
- Supporting FDA Form-2253 submissions
- DEA scheduled substance ordering and monitoring
- ISI/PI compliance and development
- Prescription Drug Marketing Act and drug sampling compliance
- State pharmaceutical manufacturing licensing
- Research and clinical study support, including drafting and negotiating Clinical Trial Agreements, subject recruitment practices
- 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