Scientific & Regulatory Consultants, Inc. (SRC) has a wide range of experience in FDA antimicrobial offerings including Cosmetic, OTC Drug, IND, ANDA, 510K, and NDA consultations. Our area of focus has been topical antimicrobial products. 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, efficacy and safety substantiation. We provide guidance in labeling and claims for various markets. We work closely with FDA staff and field offices to resolve enforcement actions, cGMP audit findings, and IND clinical holds.

SRC has established an account with FDA to assist manufacturers and distributors in electronic new drug code and manufacturing establishment listings. This portal may also be used for electronic submissions.

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
  • Preoperative preparations
  • High level disinfectants
  • Sterilants
  • Antiseptic towelettes
  • Antimicrobial hand wash
  • First aid antiseptics
  • Antifungal antiseptics
  • Skin cleansers
  • Skin protectants

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
  • Data interpretation
    • Chemistry
    • Efficacy
    • Safety
  • Facility audits
    • GLP/GMP/GCP/QSR
    • Preparation for inspections
  • Training for sales, marketing, and other staff
  • Study design
  • Protocol development and approval
  • Claims risk analysis
  • Drug master file preparation
  • FDA audit resolution/response
  • 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/representation
  • Development of innovation