Frequently Asked Questions
Following are the frequently asked questions pertaining to our regulatory affairs and quality assurance consulting services for drugs and medical devices.
- Q: Do we provide consulting
services related to quality assurance system setup within the
A: Yes. We can setup complete customized quality management system for your organization.
- Q: Do we provide core
infrastructure system ISO/QSR compliant validation services?
A: Yes. We provide core infrastructure ISO/QSR validation services for
- JDE, Oracle, SAP and Custom ERP System Validation
- Customer Relation Management (CRM) System Validation
- Document Control System Validation
- Deviation Management System Validation
- Corrective Action and Preventive Action (CAPA) System Validation
- Non Conformance Material Report (NCMR) System Validation
- Facility Master Validation
- Title 21 CFR Part 11 Assessment and Validation
- IQ,OQ, and PQ System Validation
- Q: Do we provide new medicine,
drugs or medical device product validation services?
A: Yes. We provide validation services as per ISO/QSR Design Control elements for:
- Drugs Manufacturing Systems Related Validations
- Medical Device Instrumentation System Validations
- Title 21 CFR Part 11 Assessment and Validations
- Q: Do we provide medicine, drugs
and medical device approval related services specially
interacting with FDA and EU regulatory agencies?
A: Yes. We provide drugs and medical device approval related services for IDE, 510(k), PMA, IND, NDA, BLA, Adverse Events reporting etc.
- Q: Do you provide medicine, drugs
and medical device electronic regulatory marketing submission
package creation related services?
A: Yes. We can help in creating any of the medicine, drugs and medical device electronic regulatory submission package for IDE, 510(k), PMA, IND, NDA, BLA, Adverse Events reporting etc.
- Q: Do you provide eCTD submission
A: Yes. We can help you in creating eCTD based submissions for IND, NDA, ANDA, Supplements, Amendments, Adverse event reporting etc.
- Q: Do you provide internal,
external and due diligence audit services?
A: Yes. We do provide complete internal, external and due diligence audit services based on standards of your choice like ISO9001, ISO13485, IS14971, QSR, GLP, GCP, Title 21 CFR Part 11, Title 21 CFR 210, 211 (cGMP) etc.
- Q: What are Quality Records
- Any document that pertains and/or relates to product quality
- Any record where data is captured as a result of inspection and/or test
- Any record which provides traceability
- Nonconformance related documents
- Examples of Quality Records, which are controlled by Document Control: Device Master Records (DMR), Device History Records (DHR), Validations Change Orders, Batch Records, Audit Report, Complaint Records.
- Q: What is Regulatory Affairs?
A: Regulatory Affairs (RA), is a profession within regulated industries, such as pharmaceuticals and medical devices which ensures that companies comply with all of the regulations and laws pertaining to their business and develop and market safe and effective product.
- Q: What is Quality Assurance?
A: Quality Assurance, or QA for short, refers to planned and systematic production processes that provide confidence in a product's suitability for its intended purpose (wikipedia). For detailed definition refer to http://en.wikipedia.org/wiki/Quality_assurance