Home - Regulatory Affairs and Quality Assurance Consulting Services Web Site Antrix

1 Regulatory Affairs Quality Assurance Consulting Services and Products

2 Regulatory Affairs Quality Assurance Consulting Services and Products

3 Regulatory Affairs Quality Assurance Consulting Services and Products

4 Regulatory Affairs Quality Assurance Consulting Services and Products

5 Regulatory Affairs Quality Assurance Consulting Services and Products

6 Regulatory Affairs Quality Assurance Consulting Services and Products

7 Regulatory Affairs Quality Assurance Consulting Services and Products

Regulatory Affairs and Quality Assurance
Consulting Services

Antrix offers full range of expert regulatory affairs and quality consulting services to the Medical Device, Pharmaceutical, and Biotech Industries worldwide as below: productivity gains and cost savings of up to 90%

Using our services you can achieve potential productivity gains and cost savings of up to 90%. We can provide you with complete return on investment (ROI) details for your projects.

Services

Quality Management System (QMS) Development and Deployment
Quality and Regulatory Training
Site Quality Plan, Site Regulatory Plan, Validation Master Plan and ISO 13485 Certification
Document Control and Records Management
Nonconforming Material Report (NCMR), Deviations and Corrective Action, Preventive Action (CAPA)
Internal, External and Due Diligence Audits on Acquisition Companies
Risk Management Plan, Analysis and Report as per ISO 14971, Hazards Analysis, FMEA, and FTA
Regulatory Plan, Strategy, Development and Execution for Medicinal Products, Drugs, Medical Devices and Combinational Products
Regulatory Electronic Submission Preparation and Filing for Drugs, Medical Devices and Combination Products based on eCTD and STED Standards
Title 21 CFR Part 11 Assessment and Compliance
Validation of Computer System Used in Production and/or Quality Systems
Verification and Validation of Medical Device and Research Use Only (RUO) Products
Manufacturing Process Validation
Medical Device, Drugs Labeling and Advertising
Complaint Handling, Recalls and Medical Device Reporting
Response to FDA Form 483 Observations and Warning Letter

Products

Quality System Manual, Corporate Procedures and Forms Templates
Electronic Document Management System (EDMS)
Electronic Change Order Management System (ECOMS)
Electronic NCMR, Deviation, CAPA, Supplier, Audit & Training System
Product Development and Design Control Templates
Product and Process Verification and Validation Templates
Regulatory Electronic Submission Templates