AltaQ provides global regulatory, quality, compliance, and validation consulting services. We believe in developing efficient and cost-effective regulatory solutions by understanding clients' needs and applying industry best practices to achieve success in the in-vitro diagnostics, medical device and pharmaceutical industries.
AltaQ provides services in the following areas:
Regulatory Affaris:
510(k) submissions, PMA Submissions, IDE Submissions, FDA Pre-Submissions, CE Marking, International Registrations
Quality Assurance and Compliance:
Quality System Development, Regulatory Gap Analysis and Mock Audits, Software Compliance and Validations, GMP, GLP, and GCP audits, Supplier Audits, ISO 13485, Corrective Action Management, Warning Letter Management, MDR and Recall Management, 21 CFR Part 11 compliance, CAPA
Validations:
Validation Master Planning, Process Validation, Facility Qualification, Equipment Qualification, Test Method Validation, Filling and Packaging Equipment Qualification.
Software Compliance:
Software Development LifeCycle Management, Softwware Development Plan (SDP), Software Requirement Specifications (SRS), Software Development Document (SDD), Software Verification and Validation Plan (SVVP), Software Requirement Traceability Matrix (SRTM), Software Configuration Management and Change Control Procedures, Electronic Document Management Systems, and Electronic Quality Management Systems
Company Details
- Employees
- 9
- Address
- 7200 Wisconsin Ave, Bethesda,maryland 20814,united States
- Phone
- 301.304.4888
- in****@****taQ.com
- Industry
- Business Consulting And Services
- NAICS
-
Management, Scientific, and Technical Consulting ServicesManagement Consulting ServicesOther Scientific and Technical Consulting ServicesOther Management Consulting Services
- Website
- altaq.com
- Keywords
- FDA Regulatory Approvals, Quality System, Software Compliance, Validations, 510(k), PMA, De Novo 510(k), 21 CFR 820, 21 CFR Part 11, Medical Devices, In-vitro Diagnostics, Equipment and Facility Qualification, CE Marking, International Registration, FDA US Agent, Design Control, Clinical Trials, Analytical Studies, Process Validation, Quality Audits, Quality System Regulations.
- HQ
- Bethesda, Maryland
Altaq Questions
Altaq's helpline number is 301.304.4888
Altaq's website is altaq.com
Altaq's LinkedIn profile is https://www.linkedin.com/company/altaqcom
Altaq has
9 employees.
View email and phone details for 9
employees at Altaq.
Altaq's industry is
Business Consulting and Services
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Altaq's support email address is info@AltaQ.com
Altaq's categories are Business Consulting and Services
