Quality Systems Consulting
Quality Systems Consulting Services
Quality Systems Consulting Services (QSCS) offers expert regulatory compliance, operational excellence, and validation support for medical device and pharmaceutical companies. They focus on revenue-neutral compliance, helping clients navigate FDA regulations and achieve market readiness.
Quality Systems Consulting Services (QSCS) specializes in providing comprehensive regulatory compliance, operational excellence, and validation support tailored for the medical device and pharmaceutical industries. With decades of combined experience, their team of seasoned professionals partners with clients to ensure adherence to FDA and international regulatory body requirements. QSCS is dedicated to delivering "Revenue Neutral Compliance," a unique value proposition focused on identifying and implementing opportunities for effectiveness and efficiency while maintaining regulatory adherence. This approach helps clients avoid significant costs associated with non-compliance, such as FDA 483s, Warning Letters, or Consent Decrees. Their services encompass developing, improving, remediating, and optimizing global quality systems and regulatory requirements. Whether assisting with FDA inspections, post-inspection certifications, supplier audits, or internal audits, QSCS provides hands-on guidance and strategic support. They aim to build and enhance efficient and effective quality and regulatory systems, ensuring clients achieve and remain in compliance, ultimately facilitating product launches and market access.
About
**Who they are**
Quality Systems Consulting Services (QSCS) partners with medical device and pharmaceutical companies to navigate complex regulatory landscapes and achieve operational excellence. They focus on revenue-neutral compliance, ensuring clients can bring products to market effectively.
**Expertise & scope**
* Expertise in FDA regulations and international regulatory bodies.
* Support for product submission and approval processes.
* Assistance with navigating unclear or open-ended regulations.
* Proactive strategy development for regulatory preparedness.
* Audit management and response management during inspections.
* Services include Quality Systems, Regulatory Compliance, Operational Excellence, Validation Excellence, Business Strategy & Support, Legal Services, and Remediation Solutions.
* Experience with medical device, pharmaceutical, and biologic product manufacturers.
* Onsite and remote Quality System audits.
**Reputation / proof points**
* Decades of experience in performing Quality System audits.
Quality Systems Consulting Services (QSCS) partners with medical device and pharmaceutical companies to navigate complex regulatory landscapes and achieve operational excellence. They focus on revenue-neutral compliance, ensuring clients can bring products to market effectively.
**Expertise & scope**
* Expertise in FDA regulations and international regulatory bodies.
* Support for product submission and approval processes.
* Assistance with navigating unclear or open-ended regulations.
* Proactive strategy development for regulatory preparedness.
* Audit management and response management during inspections.
* Services include Quality Systems, Regulatory Compliance, Operational Excellence, Validation Excellence, Business Strategy & Support, Legal Services, and Remediation Solutions.
* Experience with medical device, pharmaceutical, and biologic product manufacturers.
* Onsite and remote Quality System audits.
**Reputation / proof points**
* Decades of experience in performing Quality System audits.
Additional information
QSCS offers strategic support to help companies maintain compliance and prepare for regulatory inspections. They assist in developing logical defenses against potential regulatory interpretations and can act as a partner during audits and in responding to issues like FDA 483s or Warning Letters. Their approach aims to ensure that compliance efforts are not only met but also contribute positively to business operations, potentially making the compliance solution self-funding.
Key Highlights
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Offers expert regulatory compliance and operational excellence support for medical device and pharmaceutical companies.
Source
“Quality Systems Consulting Services (QSCS) offers expert regulatory compliance, operational excellence, and validation support for medical device and pharmaceutical companies.”
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Focuses on revenue-neutral compliance to help clients navigate FDA regulations and achieve market readiness.
Source
“They focus on revenue-neutral compliance, helping clients navigate FDA regulations and achieve market readiness.”
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Provides assistance with FDA inspections, post-inspection certifications, supplier audits, and internal audits.
Source
“Whether your company needs assistance with an FDA inspection, post-inspection certifications, supplier audits, or assistance in internal audits QSCS Consultants are here to help deliver compliance.”
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Possesses decades of experience in performing onsite and remote Quality System audits.
Source
“Quality Systems Consulting Services brings decades of experience in performing onsite and remote Quality System audits.”
Certifications & Trust Signals
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Supports companies in navigating FDA regulations and international regulatory bodies.
Source
“When operating within a constantly changing regulatory landscape, companies may find it challenging to keep up with and meet new guidelines and/or regulations coming from the FDA, international regulatory bodies, as well as industry groups.”
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Assists in developing strategies to address specific issues arising from inspections, such as 483s or Warning Letters.
Source
“When inspections lead to a 483, a Warning Letter, a Consent Decree, or worse, we partner with you, working with the FDA or Regulatory Bodies to develop a strategy and address specific issues to achieve and remain in Compliance”
Buyer Snapshot
Best for
- Companies needing to navigate FDA and international regulatory requirements.
- Manufacturers seeking to prepare for or respond to regulatory inspections.
- Organizations requiring support with Quality System development and auditing.
How engagement typically works
- Partnership approach to Quality System and Regulatory Compliance auditing.
- Collaborative strategy development for regulatory preparedness.
- Hands-on support during audits and inspection responses.
Typical deliverables
- Regulatory compliance strategies.
- Audit management and response plans.
- Quality System audit reports.
- Guidance on product submission and approval.
Good to know
- Best when companies require expert guidance on complex regulatory landscapes.
HQ:
San Diego, US
Languages:
English, Spanish, Chinese
Timezones:
PST, EST
Status:
listed
Services & Capabilities
FDA QMSR Transition & Inspection Readiness (ISO 13485 Alignment)
Jurisdictions:
EU, US
Countries:
US
Industries:
Medical Devices
Onboarding time:
7–14 days
Pricing model:
Custom pricing
Service Types:
QMSR/ISO 13485 Gap Assessment, SOP / Documentation Remediation, CAPA & Nonconformance Remediation, Internal Audit Program Upgrade, Mock FDA Inspection, 483 Response & Remediation Support
Earliest Start:
flexible
Delivery Mode:
Hybrid
Inspection Experience:
Former FDA investigator on team, Supports mock inspections regularly
Additional fda_qmsr_transition_inspection_readiness Details
Service Types
QMSR/ISO 13485 Gap Assessment, SOP/Documentation Remediation, CAPA & Nonconformance Remediation, Supplier Controls/Quality Agreements, Internal Audit Program Upgrade, Mock FDA Inspection, 483 Response & Remediation Support
Earliest Start
flexible
Delivery Mode
Hybrid
Inspection Experience
Supports mock inspections regularly
