top of page

About Us

Adom Consulting provides services in Regulatory Affairs (RA), Quality Assurance (QA), and Compliance Management for medical devices, pharmaceutical including API, disinfectant companies and OTC monograph product companies. Our objective is to support clients in achieving regulatory compliance, maintaining robust quality management systems, accelerating product approvals, and ensuring continuous improvement throughout the product lifecycle. With expertise in international regulations and industry standards, we provide practical, risk- mitigation solutions that enhance operational efficiency while ensuring compliance with applicable regulatory requirements

Company Profile


Adom consulting is a professional consultancy with over 12 years experience specializing in quality and regulatory compliance for the healthcare industry. We support manufacturers, importers, distributors, and contract manufacturing organizations (CMO’s) operating within regulated environments. We serve global regulatory bodies including FDA, EPA, Health Canada, TGA, MHRA, EU MDR, ANVISA, COFEPRIS.

Consulting Services

Regulatory Consulting
  • Medical Device Regulatory Compliance
  • Pharma regulatory compliance
  • GMP and GDP Compliance
  • FDA Regulatory Compliance
  • EU MDR Compliance
  • FDA ESG submissions
  • 510K preparation and submission
  • Technical Documentation Preparation
  • Agency audit support (FDA and other regulatory bodies)
  • MDSAP Audit preparation
  • Pharmacovigilance
  • Conformity assessments
  • Training and Regulatory Intelligence
  • US Agent
  • EUDAMED registration support
  • Labeling and artwork review
  • FDA facility registration and product listing
  • GS1 and GUDID registration
  • EPA Federal and State registrations
  • Board of Pharmacy state distributor license registrations
  • CTPAT Portal set up for importers
  • SAMS registration for bidding federal contracts and grants
Quality Assurance Consulting
  • ISO 13485 Implementation and Maintenance
  • ISO 9001 Quality Management Systems
  • Internal Audits and Supplier Audits
  • CAPA Management
  • Risk Management (ISO 14971)

Booking Details

Contact Us:
Contact us to schedule a virtual introductory meeting
adomconsultllc@gmail.com
1 470-219-8972

Our Business Hours

Monday to Friday, 10am to 6pm EST

bottom of page