AUK Technical Services - Dennis M., an ex-FDA investigator with 28 years in the regulatory and compliance field, is currently Chief Technical Expert and Managing Partner. Dennis brings 28 years of experience in medical device design, software design validation systems and evaluations, manufacturing software validation including ERP systems and FDA Predicate rules and the 21 CFR Part 11 rules as they apply to device firm's quality systems. Dennis has extensive experience helping firms achieve compliance to FDA regulation and International Standards regulations. Recent achievements include CE marking a medical device, helping a previously vioaltive firm achieve a no FDA 483 outcome, helping create a Combination Product Quality System; co-authoring a Technical File submission, and achieving ISO 13485:2003 and ISO 9001:2008 certification for a medical device manufacturer. 

Our Team of Former FDA Investigators and Staffers Ensure Compliance by Offering the Following Services:

    FDA Compliance | Master Planning and Strategy
    Preparation for Inspections
    Pre-approval and Mock FDA Inspections
    Vendor / Supplier Audits
    Gap Analysis
    Formal Risk Assessment
    Support with 483′s / Warning Letters / Consent Decrees
    Assistance and Review of Regulatory Filings (IND's/PMA's/NDA's/ANDA's/BLA's/510(k)'s/etc.)
    Quality Systems Guidance and Development
    Corporate SOP Guidance and Development
    Mock Product Recalls
    Assistance with Product Recalls
    Process and Utility Design Review and Assessment
    Facility Layout Review and Assessment
    Dietary Supplements and Nutraceuticals
    Assistance with Imports
    21 CFR Part 11 Compliance Strategies
    Validation Master Plans
    Equipment and Instrumentation Qualification
    Utilities Qualification
    Process Validation
    Cleaning Validation
    Analytical Methods Validation
    IT Qualification and Computer Validation
    Training and Development of Training Programs
AUK Technical Services
Description:Dennis M., an ex-FDA investigator with 28 years in the regulatory and compliance field, is currently Chief Technical Expert and Managing Partner. Dennis brings 28 years of experience in medical device design, software design validation systems and evaluations, manufacturing software validation including ERP systems and FDA Predicate rules and the 21 CFR Part 11 rules as they apply to device firm's quality systems. Dennis has extensive experience helping firms achieve compliance to FDA regulation and International Standards regulations. Recent achievements include CE marking a medical device, helping a previously vioaltive firm achieve a no FDA 483 outcome, helping create a Combination Product Quality System; co-authoring a Technical File submission, and achieving ISO 13485:2003 and ISO 9001:2008 certification for a medical device manufacturer.

Our Team of Former FDA Investigators and Staffers Ensure Compliance by Offering the Following Services:

FDA Compliance | Master Planning and Strategy Preparation for Inspections Pre-approval and Mock FDA Inspections Vendor / Supplier Audits Gap Analysis Formal Risk Assessment Support with 483′s / Warning Letters / Consent Decrees Assistance and Review of Regulatory Filings (IND's/PMA's/NDA's/ANDA's/BLA's/510(k)'s/etc.) Quality Systems Guidance and Development Corporate SOP Guidance and Development Mock Product Recalls Assistance with Product Recalls Process and Utility Design Review and Assessment Facility Layout Review and Assessment Dietary Supplements and Nutraceuticals Assistance with Imports 21 CFR Part 11 Compliance Strategies Validation Master Plans Equipment and Instrumentation Qualification Utilities Qualification Process Validation Cleaning Validation Analytical Methods Validation IT Qualification and Computer Validation Training and Development of Training Programs


AUK Technical Services
468 N. Camden Dr. , Suite 269C
Beverly Hills, CA, 90210

Phone:
Fax:

Email:

Website: www.auk.com


Products and Services: TRAINING

Quality System Regulation

Compliance Achievement

Design Control

Process Design

CONSULTING

Project Planning Assistance

510(k) Submissions

IVD Compliance

Software Compliance

Risk Management

Drug Development Capabilities

MDD Compliance

Mock GMP/ISO Audits

Preparation of Technical File for Product CE Mark Submission/Registration

Equipment Validation IQ/OQ/PQ

Sterilization Validation

MANUFACTURING ADVISEMENT PROCESSES

Injection Molding

Extrusion

Electronic Assembly

Software Production Control

Reagent & Media Batch Production

Cell Culturing

Monoclonal Antibody Diagnostic Testing Rapid Assay

Protein Purification

Sterility Testing

Aseptic Filtration

Sterile Filling and Terminal Sterilization


Experience: **Important Note: This information has been provided by the Company and has not been confirmed by Contract Laboratory Inc. It is recommended that you confirm all information prior to using this Company .


Featured Products and Services

AUK Technical Services - TRAINING

Quality System Regulation

Compliance Achievement

Design Control

Process Design



CONSULTING

Project Planning Assistance

510(k) Submissions

IVD Compliance

Software Compliance

Risk Management

Drug Development Capabilities

MDD Compliance

Mock GMP/ISO Audits

Preparation of Technical File for Product CE Mark Submission/Registration

Equipment Validation IQ/OQ/PQ

Sterilization Validation

MANUFACTURING ADVISEMENT
PROCESSES

Injection Molding

Extrusion

Electronic Assembly

Software Production Control

Reagent & Media Batch Production

Cell Culturing

Monoclonal Antibody Diagnostic Testing Rapid Assay

Protein Purification

Sterility Testing

Aseptic Filtration

Sterile Filling and Terminal Sterilization

Our staff's expertise covers the entire spectrum of quality and compliance and can be put hard-at-work for you.
AUK Technical Services - TRAINING

Quality System Regulation

Compliance Achievement

Design Control

Process Design



CONSULTING

Project Planning Assistance

510(k) Submissions

IVD Compliance

Software Compliance

Risk Management

Drug Development Capabilities

MDD Compliance

Mock GMP/ISO Audits

Preparation of Technical File for Product CE Mark Submission/Registration

Equipment Validation IQ/OQ/PQ

Sterilization Validation

MANUFACTURING ADVISEMENT
PROCESSES

Injection Molding

Extrusion

Electronic Assembly

Software Production Control

Reagent & Media Batch Production

Cell Culturing

Monoclonal Antibody Diagnostic Testing Rapid Assay

Protein Purification

Sterility Testing

Aseptic Filtration

Sterile Filling and Terminal Sterilization
Compliance & Assistance Services from Our FDA Consultants