Quality Compliance Who We Are
Quality Compliance Consulting Inc (QCCI) was founded on a simple conviction: regulatory compliance is not a burden to manage — it is the foundation of patient safety and product integrity.
With over 28 years of hands-on experience across healthcare, pharmaceutical, biotechnology, and medical device industries, we bring deep operational knowledge to every engagement. We have walked the floors of manufacturing facilities, sat across from FDA investigators, and built quality systems that withstand the scrutiny of real-world audits.
What Sets Us Apart
We are practitioners, not theorists. Our team has direct experience implementing quality management systems, conducting root cause investigations, and navigating complex regulatory landscapes. We do not hand you a binder of templates and walk away. We work alongside your team until the systems are built, validated, and sustainable.
We understand the business side. Compliance is not the opposite of efficiency — done right, it drives it. Our solutions reduce rework, shorten CAPA cycle times, and eliminate the firefighting that drains your team's energy and your company's resources.
We scale to fit. Whether you need a single specialist for a deviation investigation or a full team to prepare for an FDA pre-approval inspection, we assemble the right expertise for the scope of work. You pay for what you need, not a one-size-fits-all package.
Industries We Serve
- Pharmaceutical — Manufacturing, packaging, laboratory operations, supply chain
- Biotechnology — Cell and gene therapy, biologics, biosimilars
- Medical Devices — Class I through Class III, combination products, software as a medical device (SaMD)
- Healthcare — Hospital systems, clinical laboratories, long-term care facilities
Regulatory Frameworks We Work Within
| Framework | Scope |
|---|---|
| FDA 21 CFR Parts 210, 211, 820, 11 | Pharmaceutical & Device cGMP |
| EU MDR / IVDR | European Device Regulation |
| ISO 13485, ISO 14971, ISO 9001 | Quality & Risk Management |
| ICH Q7, Q9, Q10 | Pharmaceutical Quality System |
| ALCOA+ Principles | Data Integrity |
| MDSAP | Medical Device Single Audit Program |
Our Founder
Charles Battiste, MBA, brings over 28 years of quality and compliance leadership spanning pharmaceutical manufacturing, biotechnology, medical device development, and healthcare operations. He holds an MBA in Management from Strayer University and a B.S. in Biology from SUNY Oneonta, combining scientific rigor with business acumen.
His career spans hands-on roles at industry leaders including Novo Nordisk, Janssen, PricewaterhouseCoopers, Bristol-Myers Squibb, Siemens Healthcare, Baxter Healthcare, and Progenics Pharmaceuticals — from bench-level analytical testing to leading enterprise-wide data integrity and CAPA programs.
Core Expertise
- CAPA Management & Root Cause Analysis
- Deviation Investigation & Non-Conformance Resolution
- Quality System Auditing (Internal & External)
- Data Integrity & ALCOA+ Compliance
- Supplier Quality Management
- Risk Management (ISO 14971, 21 CFR Part 820)
- Laboratory Equipment Validation (IQ, OQ, PQ)
- Computer System Validation (CSV)
- GMP Compliance (US FDA, EMA, ICH)
Organizations Served
Novo Nordisk, Janssen (Johnson & Johnson), PricewaterhouseCoopers, Bristol-Myers Squibb, Prestige Consumer Healthcare, Siemens Healthcare, Baxter Healthcare, Sanofi Pasteur, NPS Pharma, Quantic Group, Meridian Medical Technologies, Ben Venue Laboratories, Dendreon, Progenics Pharmaceuticals, Purdue Pharma, and New York Blood Center.
Compliance is a consequence of doing things right, not a separate activity bolted on afterward.
Contact Us
Address: 137 Beechwood Avenue, Mount Vernon, NY 10553
Phone: 646-387-4580