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.