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ABOUT US

Neozene is a professional services and consulting firm providing solutions for FDA regulated industries.

20+
years of industry experience

With an average of 20+ years of industry experience, our management team is adept at developing value-added solutions based on current regulatory requirements and industry best practices tailored specifically for the needs of our clients. We help Medical Device companies navigate the increasingly complex landscape of FDA regulations so that they are equipped

with necessary foresight and scrutiny to enable better outcomes. Utilizing our extensive industry knowledge, Neozene has a variety of solutions to suit your needs. Whether you require the consulting expertise of an ex-FDA subject matter expert, assistance in growing your project team, or some added operational bandwidth, we are prepared to mobilize at a moment's notice. From small start-ups to multinational organizations, Neozene can provide the solution for your FDA compliance needs.

OUR SERVICES

Overview

Neozene-Services-Overview

Our Clients are continually surprised at the speed and level of expertise we are able to mobilize to help solve their problems within Quality and Regulatory.  Utilizing Neozene’s breadth of expertise, we are able to effectively diagnose and execute the appropriate solution in a cost effective manner. Whether it is outsourcing of an entire project or adding our Team to yours, Neozene will customize a solution to solve your Quality or Regulatory needs, large or small.

RA Services

US/EU Strategies

FDA Submission

  • PMA
  • 510K
  • Technical Files
  • Design Dossier
  • Device Classification
  • Design Control Advisor
  • EU entry
  • Interviewing International Registrar/Notified Body

EU Submission

  • Technical Files
  • Design Dossier
  • Annual Updates
US/EU Regulatory Submissions
  • 510(k)
  • Special 510(k)
  • PMA
  • PMA Supplements
  • PMA Annual Reports
  • IDE
  • IDE Supplements
  • Post Market PMA Compliance
Labeling & Marketing Development, Review, & Compliance
  • Compliance to EN 980 and ISO 15223 Symbols
  • Product Labeling
  • Collateral Marketing Materials
  • Websites
Pre-Clinical Testing Strategies
  • Bench Testing Protocol / Report development and implementation
  • Animal Study Protocol / Report development and implementation

QA Services

Quality System Implementation
  • 21 CFR 820 & ISO 13485 Implementation
  • Document and Data Control
  • Design Control Program
  • UDI implementation
  • QE Testing Program
  • Verification & Validation (V&V) Program
  • QS Metrology (calibration and preventive maintenance)
Risk Management Program
  •  Risk Management Process
  •  Failure Mode Effect Criticality Assessment – FMECA Support and execution
  •  Complaints and FMECA relationship
Audit Program
  • Internal Auditing Program
  • Auditor Support pre/during/post FDA/NB surveillance audits
  • Mock FDA Inspections
  • Inspection Readiness Programs
Approved Supplier Program
  • Supplier Qualification Program
  • Supplier Audit Support
  • Supplier Corrective Action Program - SCAR
Correction and Prevention Program
  • CAPA/NCR Program Implementation
  • Tracking and Resolution of CAPA
  • Nonconforming Materials Tracking and Resolution
  • Root Cause Investigations
Training Programs
  • Establishing a Company’s Internal Training Program
  • FDA 21 CFR 820 Quality Systems
  • EU ISO/EN 13485 Quality Management Requirements
  • Design Control Requirements
  • Risk Management
  • CAPA/SCAR
  • Root Cause Investigations
  • Good Documentation Practices

Remediation Projects

  • FDA 483 findings
  • Warning letters
  • Consent decrees
  • Previous FDA Reviewers on staff

 

Training

  • GMP/GCP/GLP/GDP
  • Design Control
  • Risk Management
  • UDI Training

Commercialization

Post market RA Compliance requirements
  • Expanding indication for use
  • Revised labeling/marketing materials
  • Letter to Files/Special 510ks
  • Annual Submission reports
  • PMA Supplement
  • Amendment submission
  • MDR/VMDR
Post market QA compliance requirements:
  • Complaints Handling
  • CAPA/NCR Management
  • Failure Analysis / Root Cause Analysis
  • RMA
  • Management Review Metrics

Case Study

  • RUO Transitioning into the IVD Market

    Neozene was approached by a diagnostics company with a portfolio of Research Use Only (RUO) products. The company's goal was to have their devices FDA cleared for commercial use in order to take advantage of the emerging market of personalized medicine.

    Business Challenge

    The company was not sure of the regulatory requirements that would govern their RUO products in the commercial market. They needed a high level Advisor to help them structure and prepare their Reagent Manufacturing Operations to be in compliance with the FDA regulations and also prepare for future growth.

    Proposed Solution

    Neozene performed a comprehensive Gap Assessment of their existing systems and developed a their strategic pathway. The results of the Gap Assessment indicated that significant modifications were required since very little existed in the way of Design History Records or Standard Operating Procedures in the company. The following steps were proposed:

    • Create and implement the reagent operational processes including all operational documentation
    • Facilitate the purchase of the necessary equipment to bring Operations consistent with industry best practices
    • Define an infrastructure strategy that would enable future growth and sustainably transition from manual to automated processes
    • Train existing personnel on cGMP and applicable regulations and requirements

    Results/Value Delivered

    The company embraced the proposal and engaged Neozene to deliver this solution. The plan was implemented over a period of 10 months and laid the groundwork for their first commercial IVD product. Neozene was also able to help the company identify and locate some used equipment at a significant cost savings.

    During the course of this project the company became aware of the strength of knowledge our consultant possessed in the area Quality Systems and assigned them the lead role in developing and implementing these systems to ensure compliance.

  • ISO 13485 CERTIFICATION PREPARATION

    Neozene was approached by a component manufacturer that supplies to the medical device industry. They were preparing for their first supplier audit from their biggest client and needed to establish a robust Quality Managment System and provide training to personnel that were unfamiliar with the regulations of the medical device industry. They approached us asking for a Quality expert to generate and implement a new ISO 13485-compliant Quality Managment System.

    Business Challenge

    The company had little knowledge of the regulations for the medical device industry and had grown significantly in a very short time. Because of this they had only a couple of SOPs in place and no formal Quality System. They were under a very tight deadline to prepare for a key supplier audit from their biggest customer and were not sure of what was needed to pass this audit and achieve ISO certification.

    Proposed Solution

    Neozene proposed getting experienced Senior-level Quality consultants to determine what processes were needed. Our consultants performed a Gap Assessment and determined that SOPs and the Quality System basically needed to be built from scratch since very little currently existed and what did exist needed significant modification. The following steps were proposed:

    • Create a project plan to prioritize the most critical SOPs for the supplier audit and put the Quality System in place to achieve ISO certification
    • Create and implement a training program to bring this facility which was not familiar with FDA and ISO regulation into compliance and have everyone understand why these changes were needed
    • Define and build a Quality Department and determine key roles needed to maintain the systems and procedures once in place

    Results/Value Delivered

    The company agreed with the proposed solution and plan presented by Neozene and engaged us on the project. The plan was implemented over 4 months and provided the company with a solid foundation for their Quality Systems and clarity on their procedures. Neozene was also able to help them determine the appropriate Quality Department structure for the company's size, current, and future needs. Neozene worked with the company to find the resources needed and converted one of our consultants into the company's first Quality Manager to lead the transition for them.

    The company also asked Neozene to evaluate their Manufacturing and Operations departments for possible improvements. Upon completion of this evaluation Neozene made a recommendation to add a resource that would help increase work flow efficiency and also help establish a culture of Quality in the company.

  • RUO Transitioning into the IVD Market

    Neozene was approached by a diagnostics company with a portfolio of Research Use Only (RUO) products. The company's goal was to have their devices FDA cleared for commercial use in order to take advantage of the emerging market of personalized medicine.

    Business Challenge

    The company was not sure of the regulatory requirements that would govern their RUO products in the commercial market. They needed a high level Advisor to help them structure and prepare their Reagent Manufacturing Operations to be in compliance with the FDA regulations and also prepare for future growth.

    Proposed Solution

    Neozene performed a comprehensive Gap Assessment of their existing systems and developed a strategic pathway. The results of the Gap Assessment indicated that significant modifications were required since very little existed in the way of Design History Records or Standard Operating Procedures in the company. The following steps were proposed:

    • Create and implement the reagent operational processes including all operational documentation
    • Facilitate the purchase of the necessary equipment to bring Operations consistent with industry best practices
    • Define an infrastructure strategy that would enable future growth and sustainably transition from manual to automated processes
    • Train existing personnel on cGMP and applicable regulations and requirements

    Results/Value Delivered

    The company embraced the proposal and engaged Neozene to deliver this solution. The plan was implemented over a period of 10 months and laid the groundwork for their first commercial IVD product. Neozene was also able to help the company identify and locate some used equipment at a significant cost savings.

    During the course of this project the company became aware of the strength of knowledge our consultant possessed in the area Quality Systems and assigned them the lead role in developing and implementing these systems to ensure compliance.

  • ISO 13485 CERTIFICATION PREPARATION

    Neozene was approached by a component manufacturer that supplies to the medical device industry. They were preparing for their first supplier audit from their biggest client and needed to establish a robust Quality Management System and provide training to personnel that were unfamiliar with the regulations of the medical device industry. They approached us asking for a Quality expert to generate and implement a new ISO 13485-compliant Quality Managment System.

    Business Challenge

    The company had little knowledge of the regulations for the medical device industry and had grown signifcantly in a very short time. Because of this they had only a couple of SOPs in place and no formal Quality System. They were under a very tight deadline to prepare for a key supplier audit from their biggest customer and were not sure of what was needed to pass this audit and achieve ISO certification.

    Proposed Solution

    Neozene provided experienced Senior-level Quality consultants to determine what processes were needed. Our consultants performed a Gap Assessment and determined that SOPs and the Quality System basically needed to be built from scratch since very little currently existed and what did exist needed significant modification. The following steps were proposed:

    • Create a project plan to prioritize the most critical SOPs for the supplier audit and put the Quality System in place to achieve ISO certification
    • Create and implement a training program to bring this facility which was not familiar with FDA and ISO regulation into compliance and have everyone understand why these changes were needed
    • Define and build a Quality Department and determine key roles needed to maintain the systems and procedures once in place

    Results/Value Delivered

    The company agreed with the proposed solution and plan presented by Neozene and engaged us on the project. The plan was implemented over 4 months and provided the company with a solid foundation for their Quality Systems and clarity on their procedures. Neozene was also able to help them determine the appropriate Quality Department structure for the company's size, current, and future needs. Neozene worked with the company to find the resources needed and converted one of our consultants into the company's first Quality Manager to lead the transition for them.

    The company also asked Neozene to evaluate their Manufacturing and Operations departments for possible improvements. Upon completion of this evaluation Neozene made a recommendation to add a resource that would help increase work flow efficiency and also help establish a culture of Quality in the company.

Office Location

7677 Oakport Street - Suite 1020 Oakland, CA 94621

Contact Us

We request you to kindly fill up the form on the left and we shall get back to you shortly.

Oakland
7677 Oakport Street- Suite 1020
Oakland, CA 94621
(510) 746- 8693
San Diego
501 W Broadway, Suite 800
San Diego, CA, 92101
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