FDA

We can help you achieve FDA compliance.

Our FDA antimicrobial offerings include Cosmetic, OTC Drug, IND, ANDA, 510K, and NDA consultations. We are available to interpret a variety of OTC monographs, including 1994 Tentative Final Monograph for Healthcare Antiseptic Drug Products and 1991 Tentative Final Monograph for First Aid Antiseptic Drug Products. Our experience spans from development (ingredient assessment and formulation), quality assurance, USP, NSF, cGMP, QSR, and efficacy and safety substantiation. We provide guidance in labeling and claims for various markets and work closely with FDA staff and field offices to resolve enforcement actions, cGMP audit findings, and IND clinical holds.

Did You Know?

The FDA has adopted the CDER Direct program to streamline annual certifications and drug listings.

We manage your annual filings for you.

SRC has an established account with FDA to assist manufacturers and distributors in electronic new drug code and manufacturing establishment listings. SRC also assists with evaluating high level disinfectants and sterilants for Premarket Notification or 510K submissions. Based on our extensive submission preparation history, we are available to prepare a wide array of FDA submissions including docket filings, IND, TEA, etc.

Product Types

  • Health care personnel hand washes
  • Hand sanitizers
  • Hand soaps
  • Surgical scrubs
  • High level disinfectants
  • Sterilants
  • Antiseptic towelettes
  • Antimicrobial hand wash
  • Preoperative preparations
  • First aid antiseptics
  • Antifungal antiseptics
  • Skin cleansers
  • Skin protectants

Our Services

  • Submission development
  • OTC data development strategy
  • Negotiation/representation
  • Registration strategy
  • Regulatory strategy
  • Problem solving
  • Drug label review and preparation
  • Cosmetic label review
  • Test lab management
  • Confidential research
  • Regulation interpretation
  • FDA audit resolution/response
  • Data interpretation
    • Chemistry
    • Efficacy
    • Safety
  • Facility audits
    • GLP/GMP/QSR
    • Preparation for inspections
  • Training for sales, marketing, and other staff
  • Study design
  • Protocol development and approval
  • Claims risk analysis
  • Food Contact Notifications
  • Drug master file preparation
  • Enforcement action resolution/response
  • Adverse event reporting
  • Novel excipient research
  • Website compliance review
  • Trade association representation
  • Review/response to new/draft regulations
  • Advisory committee presentation and representation
  • Development of innovation

Our Services

EPA  – Scientific and regulatory strategies for biocidal and pesticidal products.

FDA  – FDA antimicrobial drug and device offerings.

State Registration – Comprehensive state registrations and tracking services.

Test Management – Data development and management for efficacy, chemistry, and toxicology.

International – Global registration strategies and substantiation.

Ingredient Disclosure – Ingredient list review and disclosure assistance.

Safety Data Sheets – Authoring and analysis for proper hazard classification and communication.

Cosmetic Products – FDA and state law compliance support for cosmetics.

Other Specialties – R&D, quality, auditing, and organic materials registration.

Schedule a complimentary call with our team today!