Submissions

• 510(k)s, PMAs, de novo’s, pre-IDEs, IDEs, HDEs, Combination Products, NDAs, 505(b)(2) and INDs

Marketing

• Strategic advice on pre and post-launch marketing strategies and tactics
• Pre and post-approval communication, DTC advertising, social media, CME programs
• Promotion and advertising review, FDA and FTC advice
• Off-label dissemination (1st Amendment analysis), PR, web strategy (domestic and international)

Compliance

• Food, Drug & Cosmetic Act
• Anti-kickback and Stark analysis for sales and marketing programs
• Industry codes of conduct (PhRMA/AdvaMed/AMA/ACCME)
• Reimbursement advice (False Claims Act), Medicare rebate statute
• Prescription Drug Marketing Act
• Privacy law (HIPAA/HITECH)

Pre-Clinical/Clinical

• Trials (animal and human), FDA submissions, investigator agreements, informed consents
• Trial design, cGCP and related compliance, training; CRO assistance

Quality and Manufacturing

• TQM, design, pharmaceutical cGMPs/ISO, device QSRs, CE mark certification
• Inspection assistance, FDA representation, audits/opinions, Part 11

Misc.

• Due diligence auditing, Board of Directors’ opinions, licensing and M&A strategy