FDA Regulatory Services for ISO FDA Compliance

regulatoryservices regulatoryservices Core Compliance

Vitro Diagnostic Regulation Submissions/ Management

Regulatory Ad hoc hourly consultation and advice

Regulatory Compliance Services

Medical Device, Manufacturing, Pharmaceuticals/Supplements, Food/Beverage, Beauty and Skin Care companies pursuing commercialization need a global regulatory strategy. We offer strategic guidance for Regulatory Compliance Services at every stage of the product development process. Core Compliance supplements your organization to provide various regulatory solutions, including various product dossiers and submissions for review.

ISO Internal Audit Process

Regulatory compliance to products can sometimes feel like a moving target. The regulatory function in the healthcare industry is critical in order to ensure safe and effective products worldwide. There are considerable regulatory guidance documentation and testing requirements as well as risk assessments to be considered along the path to Regulatory Compliance. Core Compliance guide companies in the development of a regulatory road map for FDA Section 510(k) clearances, the Premarket Approval (PMA) and Biologic License Applications (BLA) processes that aligns with and your internal processes and procedures. We will help you pinpoint the information you need to develop a regulatory strategy, and then hit the ground running. Learn the next steps you need to take to bring your product or device to market. Utilize our FDA Regulatory consulting expertise to ensure FDA Regulatory Compliance.

Outsource FDA Consulting

Have you looked into Outsourcing FDA Consulting? Our FDA regulatory consultants are trained in all phases of product/clinical development and can assist in outlining regulatory/development strategies.

Hourly Ad Hoc
Short-term project
Long-term contractual agreement (Remote or Onsite)

In today’s fast changing and increasingly complex regulatory environment, it can be difficult to ensure compliance to an ever-changing array of medical device regulations in multiple countries. Many medical device companies are choosing to outsource some of their regulatory affairs and quality assurance tasks as a way to ensure compliance in these worldwide markets. Helping device companies with ongoing QMS compliance and maintain a state of compliance is critical.

ISO Internal Audit Process

Our FDA Regulatory consultants provide a clear path to compliance

FDA Regulatory Services include,

Updates to ISO Certifications ISO 13485:2016 ISO 14071:2012
CAPA (Corrective and Preventive Action)
Nonconforming Product Procedures
Complaint Procedures
Medical Device Reporting Procedures
Regulatory Submissions
483 responses
Warning Letters
Complaint Handling Procedure

Regulatory Compliance Management

Core Compliance provides regulatory compliance management with extensive experience in consulting companies throughout each aspect of FDA requirements, meeting preparation, submissions, and securing FDA market clearance/approval for devices. Outsourcing QA/RA tasks on an “as needed” basis can be very cost effective.

Full or “as needed” Regulatory Consulting for ISO Quality Assurance and Regulatory Affairs

Initial determination & classification
Create road map to FDA compliance
Outline submission/approval process
Quality/Risk Management System for ISO requirements
Fulfill requirements & prepare and maintain technical file
Perform Risk Analysis on products
Compliance with Labeling requirements (Review current marketing materials, and manual developed for users information to ensure compliance)
Prepare Declaration of Conformity & supporting evidence
Testing product Safety & Performance
Arrange meeting with applicable representative
Identify notifying body

The process will be different depending on regulatory requirements relative to the medical application, technology, and national regulations.

IDE Regulation Management

Core Compliance provides a clear understanding of requirements to IDE Regulation Management that works across all establishments primarily engaged in manufacturing IDE Regulation from diagnostic substances, such as chemical, biological, or radioactive substances.(IDE) allows the investigation to a device to be legally used in a clinical study in order to collect safety and effectiveness data required to support a Pre-market Approval (PMA) application or a Pre-market for the notification (510K).

IDE Regulation Services