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Consultants Corner > Find a Consultant

Find a Consultant

Sometimes you need a little extra help. Nelson Laboratories partners with knowledgeable consultants who specialize in the medical device, pharmaceutical and natural products industry. If you need a consultant to assist with your submission process, develop regulatory systems and controls, or train your personnel, find one here.     


John E. Lincoln & Associates, LLC
John E. Lincoln, consultant, assists companies in the design and implementation of complete 21 CFR 111, 210, 211, 820 and ISO 13485 quality management systems, fully CGMP-compliant, and which have passed FDA audits. He compiles 510(k) submissions, new and changed, product Risk Management Files / Reports per ISO 14971, Design History Files, Technical Files, and Design Dossiers. He assists companies in remediation / FDA responses, SOP writing, audits, validations, including software.   His work is described in peer-reviewed technical articles and workshops, world wide. John has also managed pilot production, regulatory affairs, product development / design control projects. He has over 28 years of experience, primarily with medical devices – working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco / Mallinckrodt. John serves on the Reader and Editorial Review Boards of MDDI Magazine, the Journal of cGMP Compliance, and writes an on-going medical device column for the Journal of Validation Technology. He is a graduate of UCLA.
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Phil Triolo
Phil Triolo & Associates is dedicated to providing medical product manufacturers technical and regulatory support to accelerate product development activities and gain quick regulatory approvals for their products. 
Services are provided  in compliance with FDA Quality System Regulations and ISO 9000 requirements.
 
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Reglera, LLC
Reglera is a leading organization specializing in quality and regulatory consulting and process outsourcing. Reglera focuses on two primary industries: medical devices and human cellular and tissue products. Since 1999, Reglera has been helping tissue and medical device companies navigate the regulatory maze through its expertise and understanding of regulatory and quality systems requirements. Whether you are developing a new product, improving an existing product, need assistance with the FDA, or are simply trying to comply with the myriad of regulation and standards, Reglera's products and services will accelerate your success and profitability. Reglera's combination of regulatory expertise and operational knowledge will accelerate your products to market and ensure compliance and operational efficiency.  This is accomplished through a combination of core competencies including: Quality Systems Development, Design Control and Structured Development, Strategic Operations, Regulatory Submissions, and Compliance Assessments and Audits.
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Microbiological Solutions, LLC

Microbiological Solutions, LLC is a consulting service company that caters to the microbiology needs of medical device manufacturers.

Microbiological Solutions can provide biocompatibility and biosafety validations, develop and validate sterilization cycles and validate controlled manufacturing environments and equipment. We can also design and implement a routine environmental test plan including validation of in house testing.

Our qualifications are based on over 15 years experience in the medical device industry backed by formal education and training.
 

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Quality Tech Services, Inc. (QTS)
Quality Tech Services, Inc. (QTS) is an established leader in outsourcing solutions for cleanroom assembly and sterile packaging of medical devices.  With significant experience in a variety of medical specialties including orthopedic, spine, urology, neurology, cardiovascular and dental, we understand the nuances critical to safe and compliant processing, yet with a rapid and cost-effective approach.
 
We provide superior cleanroom packaging and assembly services at the pace required to meet the speed of business today.  This includes innovative package design assistance, process development, material sourcing and complete project management from engineering validations and sterilization to routine processing, while maintaining traceability within ISO Class 7 Cleanroom environments.  ISO 13485 certified and FDA compliant.
 
QTS Capabilities:
  • Cleanroom Assembly
  • Package Design Assistance
  • Engineering Validations
  • Label Development & Printing
  • Cleaning & Passivation
  • Sterile & Non-Sterile Packaging
  • Tray & Pouch Sealing
  • Contract Sterilization
  • Material Sourcing & Inventory Management
  • Laboratory Test Coordination
  • Process Development
  • Project Management
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Microbiology Network, Inc.
The Microbiology Network provides expert consultation, training, and expert witness services in the areas of GMP compliance, contamination control, investigations, QC laboratory management and audits, and practical problem solving.   With over 20 years of industrial experience and 30 years of professional microbiology experience, Dr. Sutton applies proven, practical solutions to his training and consulting engagements. His solutions are based on a balance of good science, client needs, current international industry standards and an absolute clarity of purpose on the identity of the company as a profit-driven enterprise. The proof of the value of Dr. Sutton’s work can be found in the results he delivers to, and recommendations he receives from, new and repeat clients. Contact  | Visit Website
Lazzara Medical Device Quality Assurance Consulting
  • Biomedical Engineer with 25+ years industry experience in quality assurance and regulatory affairs for all device classes
  • Certified Biomedical Auditor (American Society for Quality)
  • MS Engineering- Case Western Reserve University
  • BS Engineering- Brown University
  • Services
    • Quality System Design and Implementation
    • Quality Audits- Internal, Mock FDA/Notified Body
    • Quality Engineering
    • Risk Management
    • Standards Identification/Interpretation
    • Plans, Protocols, Reports
      • Product design verification/validation (shelf life)
      • Biocompatibility evaluation
      • Packaging validation
      • Sterilization validation
      • Process validation
    • Product Complaint Management
    • Post Market Surveillance
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Custopharm, Inc.
CUSTOpharm is a customer-focused service company that provides personalized cost-effective chemistry and manufacturing controls (CMC) and regulatory support to companies .
 
CUSTOpharm received approval from the FDA to submit via the ESG in May 2008. Since that time 375+ filings have been done using the ESG. In 2009 we submitted in excess of 150 ESG submissions.  Utilizing the ESG can enable an organization to submit to the FDA without using paper, pressboards or couriers. In addition to less hassle, utilizing the ESG can save organizations valuable resources like time and money.
 
CUSTOpharm filed their first eCTD in 2004. Since that time 80+ product filings have been submitted using eCTD format.
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Indigo Consulting Group, LLC
We support the Medical Device and Pharmaceutical Industry including Combination Products by providing Sterilization Program management and validation services; Pre and Post Market Clinical Literature Reviews supporting Risk Management Programs under the revised MDD; Regulatory Compliance Programs including Regulatory Responses, Internal and Supplier Audit Programs, CAPA and Vigilance Systems for US, Canadian, and European Markets.
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NJK & Associates, Inc.
NJK & Associates provide quality, regulatory, and engineering expertise to medical device and in-vitro diagnostics clients worldwide. We provide a full range of services including:
  • Preparation & submission of Pre-IDE, IDE, 510(k), PMA
  • Development of regulatory strategy
  • Guidance on verification and compliance testing to support regulatory submissions
  • Assessment of impact of recent FDA actions and policies
  • Remediation of FDA enforcement actions
  • Design of clinical studies
  • Evaluation of data
  • Communication & meetings with FDA
  • Review of labeling & marketing literature
  • Internal, due diligence, and supplier audits
  • Creation & administration of compliant quality systems
  • Completion of design history files and technical files
Our services are primarily provided in a hands-on manner. We take pride in helping clients to achieve success in a timely, cost-effective, and compliant manner.
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Booth Scientific, Inc.
Anne F. Booth is a quality GMP and sterilization specialist with over 25 years of experience in the field of medical device and pharmaceutical manufacturing. She has worked for three medical manufacturers as Microbiology and Sterilization Services Manager/Director and a contract sterilizer as Director of Validation. In each of these positions she provided technical support in the development, validation and management of GMP compliant sterilization programs. Ms. Booth's experience has also included establishing sterilization support testing labs and environmental monitoring programs, developing quality manuals and performing audits, validating cleanrooms and manufacturing processes and recommending cleaning and sterilization programs for reusable devices. She established an independent consulting business, Booth Scientific, Inc., in 1994 which has provided optimal GMP and sterilization programs for more than 50 medical device and pharmaceutical manufacturers. Contact  | Visit Website
“I am always very pleased with the service provided by Nelson Laboratories. I highly recommend them. Great customer service and prompt reporting results are very helpful to my RA/QA job function.”

Barbara , RA/QA , Medical Device Manufacturer
MN:BARRACUDA