FDA Regulatory Consulting Services

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At Smart Consulting Group we pride ourselves on the personal connections we establish with each one of our clients. As experts in FDA regulatory consulting, we work tirelessly to not only understand the unique compliance issues that are effecting each of our clients’ distinct pharmaceutical environments, but to also ensure that an exceptional relationship develops between our consultants and clients. By doing this our team provides effective, professional results that gives your company the competitive edge in the industry.

As a team Smart Consulting Group works closely with the FDA, while staying current with industry guidelines and government standards. This is the SCG promise.

NAICS Code: 541690, 541611, 541614, 541618

Take a look at our FDA regulatory services:

  • Regulatory strategy
  • Regulatory project management
  • Advertising promotion and labeling
    • Strategy
    • Medical, legal and regulatory review
    • Package insert
    • Website and social media
  • Labeling strategy
    • Initial
    • Expansion
    • 505 (b) 2 submissions
  • Regulatory agency meeting preparation
    • Preparation for advisory committee meetings
    • Preparation of milestone meeting documents
    • Operational briefing documents
  • Regulatory submission support IND and NDA BLA 510 K
    • IND/CTA preparation
    • Conversion of IND to eCTD format
    • Annual reports CBE and PAS submissions
    • Assessment of safety surveillance systems
    • State licensing for storage and distribution
    • Due diligence

If you would like to know more about our FDA consultants or regulatory consulting services, please email us at inquiries@smartconsultinggroup.com or call us directly at 610-344-9218. We look forward to hearing from you!