Scientific & Regulatory Consultants, Inc. (SRC) develops and manages data generation on behalf of clients seeking new product offerings and amending existing products in the antimicrobial marketplace. We have extensive experience managing timely contract laboratory services with labs in the U.S. and overseas. SRC is available to conduct on-site Good Laboratory Practices (GLP) and Good Clinical Practices (GCP) audits to ensure studies and final reports are acceptable to various agencies. Our firm has established relationships forged over many years with the laboratories whose data is submitted to EPA, FDA, and international bodies. Our team actively participates in standards setting bodies including ASTM, OECD, AOAC, and NSF.

SRC regularly counsel clients about strategic data development to control laboratory costs while providing valuable test points to manage decisions regarding claims, formulation development, and labeling regulations. We consistently monitor the changing domestic and international data requirements to confirm protocols and final reports will support product registration and desired marketing claims. Because our consultants include professionals in all areas of data requirements, the entire suite of required data can be managed through our firm for U.S. and/or international registrations.

Product Types

EPA

  • Disinfectants
  • Non-food sanitizers
  • Food contact sanitizers
  • Pool and spa products
  • Treated articles
  • Residual products
  • Pond care products
  • 25(b) formulations
  • Pesticidal devices
  • Adjuvants
  • Water purifiers
  • Fungicides
  • Tuberculocides
  • Virucides
  • Mildewstats
  • Active ingredients
  • Inert ingredients
  • In tank sanitizers
  • Carpet treatments
  • Air sanitizers
  • Biofilm treatments
  • Soft surface sanitizers
  • Textile treatments
  • Insecticide
  • Rodenticide
  • Natural products
  • Algicides
  • Water treatments

FDA

  • 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

  • Microbiology
  • Chemistry
  • Toxicity
  • Source contract laboratories
  • Design screen testing strategy
  • Data development strategy
  • Design test protocols
  • Study management
  • Good Laboratory Practices (GLP)
    • In-process study audits
    • External QAU Services
    • Preparation for inspections
    • SOP preparation
  • Scientific problem solving
  • Design innovative test methods
  • New protocol submission development
  • Laboratory negotiation/representation
  • Label review
  • Regulation interpretation
  • Data interpretation
    • Chemistry
    • Efficacy
    • Safety
  • Protocol compliance review
  • Final report compliance review