When one considers a group of knowledgeable and experienced professional engineers, medical device and pharmaceutical regulatory consultants, quality assurance and reliability experts, merged with a talented sales team dedicated to online medical supplies, what you get is E & E Medicals and Consulting. We have well-established partners in the EU, Asia, and USA.
We have the most exceptional access to a team of consultants who are very experienced with the U.S. Food and Drug Administration (FDA) and the healthcare industry. E& E Medicals provides the following services:
Medical Device and Diagnostics
o Investigational Device Exemption (IDE)
o Premarket Notification 510(k), DeNovo, PMA
o Establishment Registration
o US Agent for Foreign Establishments
Drugs / Biologics / Pharmacovigilance
o Investigational New Drug (IND) Application
o New Drug Application(NDA)
o Abbreviated New Drug Application (ANDA)
o Biologics License Application (BLA)
o Drug Master File (DMF) Submissions
o Chemistry, Manufacturing, and Control (CMC)
International Regulations, Approvals, Licensing and Compliance
o CCC Mark Approval
o CE Mark Approval
o EU MDR/IVDR Technical Documentation
o Post-market Compliance
o FDA 483 Warning Letter/Recalls and Remediation
o Canada License Applications
o Regions: APAC, LATAM, EMEA, ASEAN, META
HEALTHCARE CONTINUOUS IMPROVEMENT
o Reliability
o Six Sigma - Healthcare
QUALITY ASSURANCE
o Medical Devices
o Audits
o Reliability
o Quality System Regulation
o Quality Management System Implementation
QUALITY SYSTEMS IMPLEMENTATION, ISO CERTIFICATION
o ISO 13485 Quality System Registration
o ISO 14971 Device Risk Management
o ISO 9001 Quality Management System
o Free ISO 13485:2016 Gap Analysis Tool
o Free ISO 9001:2015 Gap Analysis Tool
Company Details
- Employees
- 2
- Founded
- -
- Address
- 400 Galleria Pkwy Se,
- Industry
- Manufacturing
- NAICS
-
ManufacturingBeverage and Tobacco Product ManufacturingMiscellaneous ManufacturingTextile Furnishings MillsOther Textile Product MillsOther Miscellaneous ManufacturingCarpet and Rug MillsCurtain and Linen MillsTextile Bag and Canvas MillsAll Other Textile Product MillsJewelry and Silverware ManufacturingDoll, Toy, and Game ManufacturingOffice Supplies (except Paper) ManufacturingSign ManufacturingAll Other Miscellaneous ManufacturingRope, Cordage, Twine, Tire Cord, and Tire Fabric MillsAll Other Miscellaneous Textile Product MillsGasket, Packing, and Sealing Device ManufacturingMusical Instrument ManufacturingFastener, Button, Needle, and Pin ManufacturingBroom, Brush, and Mop ManufacturingBurial Casket Manufacturing
- Website
- eemedicals.com
- Keywords
- Six Sigma - Healthcare, FDA 820 - Quality System Regulation, ISO 13485 Registration, ISO 14971 Risk Management, ISO 9001 Quality Management System, CCC Mark Approval, CE Mark Approval, EU MDR/IVDR Technical Documentation, Post-market Compliance, Medical Device Licence (MDL), Medical Device Establishment Licence (MDEL), Investigational Device Exemption (IDE), Premarket Notification 510(k), DeNovo, PMA, Establishment Registration, Investigational New Drug (IND) Application, New Drug Application(NDA), Abbreviated New Drug Application (ANDA), Biologics License Application (BLA), Drug Master File (DMF) Submissions, Chemistry, Manufacturing, and Control (CMC), and APAC, LATAM, EMEA, ASEAN, META.
- HQ
- Atlanta, Georgia
E & E Medicals And Consulting Questions
E & E Medicals And Consulting's website is eemedicals.com
E & E Medicals And Consulting's LinkedIn profile is https://www.linkedin.com/company/e-e-medicals-and-consulting-llc
E & E Medicals And Consulting has
2 employees.
View email and phone details for 2
employees at E & E Medicals And Consulting.
E & E Medicals And Consulting's industry is
Manufacturing
E & E Medicals And Consulting's top competitors are
The Children's Center For Therapy And Learning,
Alberta Health Services,
Fraser Health Authority,
Miller Thomson Llp,
E&e Medical Supplies Ltd.,
Baxter International Inc.,
Ao Globe Life,
Resilience,
Healthtech Consultants,
Centricity Research.
E & E Medicals And Consulting's categories are Manufacturing
E & E Medicals And Consulting's founding year is 2018
