Mentor Documents and Consulting
Comprehensive Consulting for:

Responses to FDA 483 warning letters

Construction projects for science and technology

Validation projects

Medical device and pharmaceutical drug manufacturers

Commissioning & Qualification C&Q
Piping & Instrumentation P&ID
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Laboratories
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Clean rooms
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Medical Device and Pharmaceutical Drug Manufacturing and research facilities
Legionnaires
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AHRAE 514 Water management facility requirement for the prevention of Legionnaires
Medical Device Manufacturing 21 CFR 820 and ISO 13485:2016
510(K) Submissions
GUDID UDI Labeling Compliance
Design Control
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Design Validation
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Design Master File
ISO 11135 Ethylene Oxide Sterilization of healthcare products
Risk Assessment Risk Management ISO 14971 Risk Management
ISO 11737-1:2018 Sterilization of health care products — Microbiological methods
Product Recall
Post Market Management
Vendor / Supplier Management
Quality Agreements
EQMS
Quality Management Systems
Pharmaceutical Drug Manufacturing 21 CFR 211
IT Systems; Document Management 21 CFR Part 11 ISO 9001 Eudralex V4
Annex 11 – ISPE GAMP 5
FDA EU GHA ISO ICH COFEPRIS
CAP, CLIA, JACHO, GCPs, cGMPS, ICH guidelines
SOP development / Technical Writers
Change Management
Metrology / Calibration
Project Management
Process Improvement & Implementation
Risk Assessment Risk Management ISO 14971 Risk Management
FDA remediation 483 response letters; inspection hosts
Global Research and Development
QSR to QMSR
Auditing
ISO 19011:2018 Trained Auditors
(NMPA) National Medical Products Administration (formerly CFDA) Chinese Food and Drug
(SAMR) State Administration of Market Regulation
SENASICA-COFEPRIS (Mexican FDA)
PMDA (Japanese FDA)
Cleaning and Sterilization Validation Projects
ISO 11737-1:2018 Sterilization of health care products — Microbiological methods
ISO 11135 Ethylene Oxide Sterilization of healthcare products
Biotechnology
Pharmaceutical
General Manufacturing
Qualification
Specification development
Process Validation
IT Software Systems Validation
IT Systems Documentation
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21 CFR Part 11 ISO 9001 Eudralex V4 Annex 11 – ISPE GAMP 5
Statistical Analysis
Disparity Studies
Data Analytic
Quality and Compliance
NAICS Codes
325410 Pharmaceutical and Medicine Manufacturing
325411 Medicinal and Botanical Manufacturing
325412 Pharmaceutical Preparation Manufacturing
325413 In-Vitro Diagnostic Substance Manufacturing
325414 Biological Product Manufacturing
339112 Surgical and Medical Instrument Manufacturing
339113 Surgical Appliance and Supplies Manufacturing
339114 Dental Equipment and Supplies Manufacturing
339115 Ophthalmic Goods Manufacturing
541330 Engineering Services
541600 Management, Scientific, and Technical Consulting Services
541611 Administrative Management & General Management Consulting Services
541614 Process, Physical Distribution, and Logistics Consulting Services
541618 Other Management Consulting Services
541690 Other Scientific and Technical Consulting
541990 All Other Professional, Scientific, and Technical Services
561311 Employment Placement Agencies
561410 Document Preparation Services
611430 Professional and Management Development Training

Mentor Documents and Consulting specializes in providing tailored consulting services to medical device and pharmaceutical drug manufacturers. Our expertise includes construction projects for critical scientific technical buildings such as clean rooms, laboratories, and facilities dedicated to research or manufacturing. Additionally, we offer strategic solutions for manufacturers, new product endeavors and government institutions, ensuring compliance, industry best practices, efficiency, and innovation.
Mentor's commitment to excellence is evident in every aspect of our operations. Our emphasis on fair pricing and equitable treatment of consultants ensures a harmonious collaboration between all parties involved. By maintaining robust management oversight on every project, we guarantee customer satisfaction and work that exceeds expectations.
Our consultants are not only diversely skilled but come highly recommended for their expertise in navigating complex industry standards and methodologies. Each team member brings a wealth of technical experience and training, staying abreast of industry changes to deliver unparalleled results.
Our auditors excel at preparing organizations for seamless inspections, while our management team is ready to intervene and realign efforts whenever client expectations are at risk. Through improved turnaround times and performance in challenging environments, our consultants consistently set the bar higher, embodying our ethos of professionalism and dedication.
We offer our services in both English and Spanish. Our founder is a former member of the National Association of Judicial Interpreters & Translators.
Who We Serve

Manufacturing Facilities

Utilities

Government Entities

Construction

Regulated Businesses

International

Latin America (Globally)
Nuestra empresa habla y escribe en español e inglés.
Certified Clinical Trial Management
Certified Project Management
ASQ: Certified Quality Improvement
Certified ESBE, HABE, HUB, WBE, MBE, SBE
LAMPS HC Info Cloud-based Water Management Plans partner
Parental Drug Association (PDA)
Who Are The Mentors?
Our team consists of USA educated top industry executives, PhD’s, chemists, quality directors, and engineers. All consultants adhere strictly to industry confidentiality practices. Our collaborative efforts provide expert guidance for your organization to optimize success.
Our experts are vetted and hand-picked industry specific experts that are available at a moment’s notice. Whether you’re developing new products, initiating clinical activities, increasing your manufacturing, validating your processes, or starting a new venture, we have what you need.
The people who shape our organization are some of the best in the industry. They are dedicated to making an impact and are with you every step of the way. We strive to meet the most pressing needs, solve the most complex problems, and go beyond expectations for our clients with unrivaled customer service!

Mentor
Documents And Consulting
Location
San Antonio, Texas, USA
Serving Texas, USA, Mexico and the World in English and Spanish
Contact Info
Phone: (210) 236-1764
Email: consultant@mentordoc.com
We offer services in English and Spanish. Nuestra empresa habla y escribe en español e inglés.
