Managed Services
Core Compliance is a Managed Service Provider for companies requiring specific skills and expertise for FDA Regulatory industry and ISO consulting related projects. Our stable of SME consultants provide flexible options for your organization to fulfill needs staff augmentation for long and short-term projects, audits, training, expert advice, and more. Keep your critical projects moving forward with fully vetted, skilled personnel who meet your most complex related requirements, demonstrate exceptional performance and increase the productivity of your managers and internal staff.
Companies can utilize our consulting expertise for the following scenarios,
- Ad Hoc hourly or daily rate
- Short-term project based
- Long-term extended contractual agreement
Projects ISO Consulting
- ISO Standards training/implementation
- ISO Standards certification update (ISO 9001:2015, ISO 13485:2016)
- Registrar Audit Certification Training
- Tailored End User Training
FDA Regulatory Consulting
- Regulatory assessment
- FDA inspection preparation
- FDA Regulatory Audits
- Document auditing of clinical protocols, IBs, eCRFs, CSRs
- Supplier/Vendor auditing
- GMP Facilities
- Medical device audits for 21 CFR Parts 820 (QSR and QSIT audits)
- MDD/IVDD/AIMDD Compliance Audits
- Mock FDA GxP inspections
- Mock Pre-Approval Inspection (PAI)
- Multi-Country Registration and Approvals
- Preparation of responses to FDA 483, citations, and warning letters
- Quality System/GMP Audits using FDA QSIT Techniques
- Routine internal audits
- Software Quality Assurance and SW V&V Auditing
- Strategic GxP Compliance Consulting: GCP, GLP, GCP
- Supplier QA audits
- Supply-chain audits
- Global regulatory strategy development
- Pre-IDE meeting preparation
- Pre-IDE meeting participation
- Pre-market submissions: 510(k), PMA, BLA, HDE
- FDA advisory panel preparation and meeting support
- GxP Validation Services- software, hardware, validation, data capture, IVRS, safety, systems
- QMS development process mapping, development
Flexible Contracts
Select the time frame that fits your organization, we have hourly, daily, weekly, monthly semi annual and annual contracts. Onsite and remote for your ISO staff augmentation needs.
Member of your Team
Our subject matter experts work side by side with your team to achieve company goals and milestones, team focus on your long-term IT optimization and service improvements. This means that we’re constantly looking for ways to improve the service. Get a quote
ISO Expertise
ISO consulting industry related expertise, for projects short or long term. Our consultants can provide staff augmentation needs for implementation, training, subject matter expertise for consulting and registrar audits as a member of your team .
ISO 9001:2015 –Quality Management Systems
ISO 13485:2016 FDA Compliance 510K Submission CE Marking –Medical Devices Quality Management Systems
ISO 17025–Testing & Collaboration Laboratories Management
AS 9100–Aerospace Industry Quality Management Systems
ISO/IEC 20000:2011–Information Technology Service Management
ISO/IEC 27001:2011–Information Technology Security Management
R2:2013 RIOS Electronics Recycling NAID –Information Destruction e-Stewards –Responsible Recycling and Reuse of Electronics
ISO 14001– Environmental Management Systems
OHSAS 18001 ISO 45001 –Occupational Health & Safety Management
ISO/TS 16949-Automotive Industry Quality Management Systems .
ISO Consulting Positions & Roles
ISO Consultants
- ISO Quality Management Consultant
- ISO Implementation Consultant
- Regulatory Affairs Quality Consultant
- Quality Consultant ISO 9001:2015
- ISO Quality Management System Consultant
- Quality Assurance/ISO Regulatory Compliance Manager
- ISO 13485 Medical Devices Consultant
- ISO 14001 EHS Consultant
- Environmental Health & Safety Specialist Consultant
- OHSAS 18001 Consultant
- R2 Consultant
- RIOS Consultant
- E-Stewards Consultant
- NAID Consultant
- ISO/IEC 20000 Consultant
- Information Security Management Manager
- Information Security Analyst
- ISO/IEC 27001 Consultant
- IT Security Operations
- Internal Auditor
FDA Regulatory Consulting Positions & Roles
FDA Regulatory Consultants
- FDA Consultant
- FDA Regulatory Compliance Auditor
- Quality Assurance Compliance Auditor
- Quality Manager/Quality Control
- Director of Regulatory & Quality
- Regulatory Affairs Consultant
- Regulatory FDA Affairs
- Labeling Regulatory Compliance Specialist
- Regulatory Business Analyst
- Regulatory Consultant
- ISO 13485 ISO 14971 ISO 9001 Specialist
- Pharmaceutical Business Analyst
- CMC Regulatory Affairs (Chemistry, Manufacturing, and Controls)
- GMP Manufacturing Consultant – (Good Manufacturing FDA)
- FDA Safety & Submissions Expert Consultant (510K CE Mark Health Canada)
Safety & Environmental Consultants
Safety & Environmental Consultants
- Regulatory & Environmental Compliance
- Safety & Regulatory Compliance Leader
- Energy/Utility Analyst
- EHS Manager
- EHS Consultant
- R2 Consultant
- RIOS Consultant
- E-Stewards Consultant
- NAID Consultant
- Environmental Health & Safety Specialist Consultant
- OHSAS 18001 Health & Safety Consultant
Validation & Technology Development Consultants
Validation Technology Development
- Validation Consultant
- Software Implementation Consultant
- FDA Software Validation Consultant
- Computer Systems Validation Specialist
- Governance, Risk, and Compliance Analyst
- Clinical Informatics Subject Matter Expert- (Health Information Systems)
- Developer/Data Analyst
- Data Warehouse Developer
- BI Analytics Consultant
- Oracle Agile PLM consultant (PQM)
- Oracle OBIEE E-Business Suite
Regulatory Medical Device Consultants
Summary–
Provides regulatory affairs, compliance and quality consultative services for early-stage and established Class I/II/III device, In Vitro Diagnostics, and bio/pharmaceutical manufacturers on the global landscape.
Experience–
25 Experience-years of Areas of Regulatory Affairs, Compliance and Quality Systems. Previous responsibilities consulting medical device manufacturers, including a globally recognized CRO and has worked directly with manufacturers engaged in compliance remediation activities and services involving consent decrees, CIA’s, warning letters, 483 observations, and customer generated compliance events, and prepares for and conducts QS and regulatory audits.
Expertise–
- FDA regulations, including 21 CFR 210/211, 21 CFR 820 QSR, GMP Quality System implementation
- Leads and directs activities for the registration and approval process and working with Agencies in the Pacific Rim, EU and The Americas, including but not limited to FDA, European Medicines Agency–EMA, MHRH, ANVISA, PMDA, TGA, and Health Canada
- Compliance requirements, GxP training
- Constructing, reviewing, and/or remediating regulatory submissions, including 510(k), PMA, IDE applications, BLA and NDA submissions
- Preparing Supplements, Amendments
- S. Agent for clients work closely with the key stakeholders and Agency/Center Reviewers
Submission meetings and negotiations; clinical affairs and study submissions; and provides regulatory submissions and post-market project leadership and guidance covering different therapeutic and medical specialties based on classification.
R2 RIOS Electronics Recycling Consultant
Summary–
Provides education in the electronic recycling industry, compliance and quality consultative services for early-stage and established recycling organizations.
Experience–
20 Experience-years of ISO auditing, Compliance and Quality Systems and on the a technical adviser for SERI the governing body of R2 certification.. Previous responsibilities consulting electronic recycling manufacturers, including expertise for R2, RIOS, e-Stewards, NAID audits.
