Regulatory Strategy
Regulatory industries including pharmaceuticals, medical devices, foods, dietary supplements, and cosmetics have significant regulatory demands with multiple regulations for compliance. Are you looking for third party regulatory expertise to provide strategy, preparation, and submissions to ensure compliance? How do you mitigate risk in eliminating violations that can affect your organization? Core Compliance Regulatory consultants provide the information and training you need to manage all aspects of regulatory compliance & requirements. Including 510k submissions, pre-market approval (PMA), and Investigation Device Exemption (IDE) for clinical studies.
- Review of corrective actions and recommendations for resolution
- Supporting quality metrics and analysis as part of the management review meetings
- Reviewing labels and advertising for compliance with regulations
- Internal auditor training, risk management, quality system, or other training needs.
- Complaint handling, contract review and surveillance audits.
- Document control and maintenance of the quality system.
- Responding to 483 Observations, Warning Letters and Notified Body audit findings
Regulatory Services
Our experienced consultants provide comprehensive Regulatory services & clinical guidance for all types of companies, including onsite and remote online options. Our expertise with FDA requirements provide a clear road map for your organization’s regulatory needs.
FDA Regulatory Consulting Services
- Regulatory 3rd party consulting-Strategy, Preparation, Implementation and Representation
- ISO Compliance
- Submission Management-510k CE Mark Health Canada Compliance
- Software Validation
- cGMP Compliance
- Audit Services– Audits of your quality management system or a supplier’s quality system
Quality Assurance/ ISO Compliance
Core Compliance provides consulting services that include quality assurance & ISO compliance with eliminating the headaches for companies looking to maintain or become compliant to ISO and regulations. We have experienced ISO consultants providing that can guide your organization through every step to ISO compliance.
Flexible Consulting Services
No matter the situation, we can provide Regulatory Consulting Services to ensure compliance. Get an initial free consultation for one hour to see if we can provide expertise.
- Hourly Ad Hoc
- Short-term
- Long-term extended
Find out more for pricing and services-
ISO Internal Audit Process
Outsource the medical device submission compliance process to our regulatory expertise. Before you can offer your medical products to nations must comply regulatory requirements that manufacturers of medical devices distributed in the U.S. must comply, registration, medical device listing, Premarket Notification 510(k), Investigational Device Exemption (IDE).
Europe CE Mark compliance
Canada Health Canada Medical Device License (MDL)
Regulatory Audit Services
Do you have a pending audit? We provide regulatory audit services with experienced consultants to provide a health check and ensure compliance. Our consultants evaluate current state, outline the applicable country requirements and prepare and train your organization to prep for the audit.
Core Compliance can step in and guide your company to regulatory compliance at all stages, manage product quality, personnel performance, and production efficiency. Flexible options hourly, daily, monthly options are available.
Audits services include:
- CAPA
- CE Mark 510k submission management
- Compliance audits
- Computer systems audits and Part 11 assessments and remediation
- Comprehensive remediation strategies
- Due Diligence and Compliance Audits, Assessments and Remediation Strategies
- GMP, GLP and GCP environments
- Gxp Audits
- ISO 13485/ISO 9001
- 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)
- Validation audits
GMP Compliance Services
Core Compliance provides GMP compliance services. Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. Core Compliance has extensive FDA experience in guiding Medical Device, Pharmaceutical companies a clear road to GMP cGMP FDA compliance. Start GMP Compliance cGMP regulations enforced by the US Food and Drug Administration (FDA). CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. See facts about good manufacturing practices- Learn More
Software Validation Services
Our consultants provide professional Software Validation Services for Facilities, utilities, environmental controls, equipment, processes, test methods, cleaning, computer systems, packaging, shipping application software, spreadsheets, and databases that affect or contribute to product quality are all subject to qualification or validation. Medical device design validation and design transfer for manufacturing requires expertise.
What are the validation requirements that apply to a specific system or process? How do you validate a manufacturing process, a software application or computer system? FDA Compliance outline.
Our services include:
- Computerized System and Software Validation (Learned & Maintenance Management Systems)
- Development of Validation Policies, Templates & Procedures
- Corrective Actions/Preventive Actions (CAPA) and Complaint Management Systems
- Manufacturing Execution Systems (MES)
- Managing Plant Relocation and re validation
- Master Validation Planning
- Protocol Development
ISO Standards
