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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

Mentor Documents and Consulting

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Nuestra empresa habla y escribe en español e inglés.

Services

Facility Construction Projects

Commissioning & Qualification C&Q

Piping & Instrumentation P&ID

  • Laboratories

  • Clean rooms

  • Medical Device and Pharmaceutical Drug Manufacturing and research facilities

Legionnaires

  • AHRAE 514 Water management facility requirement for the prevention of Legionnaires

Comprehensive Regulatory Support

Medical Device Manufacturing 21 CFR 820 and ISO 13485:2016

510(K) Submissions

GUDID UDI Labeling Compliance

Design Control

  • Design Validation

  • 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) 

Validation Projects

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 

  • 21 CFR Part 11  ISO 9001 Eudralex V4 Annex 11 – ISPE GAMP 5

Government Projects

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

Services Statement

apartment balconies representing orderly reports

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)

Certifications & Affiliations

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

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.

Contact Us

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