• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Blog
  • News & Events
  • Videos
  • Resources
main-logo-small

Compliance Architects

Consulting Technology Outsourcing

  • About Us
    • Senior Staff
    • Why Us
    • Mission And Vision
    • Clients
    • Partners
    • Career Opportunities
  • Services
    • Inspection Readiness & Enforcement
      • FDA Inspection Readiness
      • Audits & Assessments
      • FDA Enforcement Response/Remediation
    • FDA Quality Consulting
      • Quality System & Compliance Turnarounds / Restructuring
      • Training / Coaching
      • Quality & Compliance Computer-Based Systems
      • External Supply Chain Compliance
      • Part 11 & Computer Systems Validation
      • Turnkey Quality Systems
    • Quality Assurance and Engineering
      • CRPN Quality Roadmap®
      • Quality Culture Assessment
      • Product Quality Consulting
      • Operational Efficiency/Compliance Effectiveness
      • Project/Program Management
    • Corporate Compliance and Litigation
      • Corporate Compliance Programs
      • Interactions With Department Of Justice And The Courts
    • FDA Regulatory Consultants
      • Product Development / Submissions / Commercialization
      • REMS (Risk Evaluation And Mitigation Strategies)
      • Mergers / Acquisitions / Licensing
    • Quality, Compliance, Regulatory & Operations’ Staffing
      • Staffing
      • Talent Management
      • Rapid Turnaround
  • Innovative Solutions
    • Writing for Compliance®
    • CRPN Quality Roadmap®
    • Quality Pulse®
    • IEEP
    • REMS
  • Success Stories
  • Industries
    • Biopharmaceuticals
    • Cannabis/CBD
    • Cell & Gene Therapies
    • Combination Products
    • Cosmetics
    • Dietary Supplements
    • Medical Devices and Diagnostics
    • Pharmaceuticals
  • Contact Us

Seven Things to Consider When Selecting a Pharmaceutical Quality Consulting Firm

Selecting a pharmaceutical consultant to help your organization with GMP, quality and compliance concerns can be a daunting task for any Quality executive. This is especially true for new or smaller companies that do not have existing relationships with consulting firms or solo consultants. The sheer volume of options in 2019 can make your head spin!

Selecting the right pharmaceutical quality consulting firm is often one of the most important decisions an executive will make, mostly because projects in this functional area are so critical to a company’s business performance, and a project’s success is contingent on the selected firm’s competency and ability to achieve desired outcomes.

While there could be dozens of factors to consider prior to making a selection, the following are the seven key topics we believe will help to ensure your company chooses the most qualified, “best fit” consultant for your business and specific FDA quality and compliance concerns.

  1. PROVEN CLIENT SUCCESS

Most pharmaceutical quality consultants have a section on their website dedicated to case studies or client testimonials. Taking the time to read through reviews and case studies is critically important and should be reassuring.  Look for companies, FDA-regulated products or compliance problems that are similar to yours, and investigate how the consultant handled the problem and if the solutions and practices they deployed could benefit you.

  1. SPECIALIZATION

Ensuring a consultant’s expertise is in line with your needs is paramount.  Identifying firms that will consider your unique business model, organizational structure and culture is important for optimal outcomes.  For example, some consulting firms prefer checklist or “check the box” solutions which don’t take into considerations the company’s operating model.  This sort of approach often results in solutions that require layer upon layer of checks and rechecks, after which the firm announces, “problem solved” and moves on.  By comparison, the best firms aim higher and help clients make “step-changes” in regulatory, compliance and business performance outcomes.  With so much nuance in the pharma industry, be sure to research and see if a consultant’s mindset and skills are congruent with your organization’s needs. We suggest looking at the consultant’s portfolio of similar work, work history, references and educational background.  Often, this can be done via LinkedIn or the consultant’s website.

  1. THOUGHT LEADERSHIP

If a consultant is regularly featured as a speaker or moderator at industry events, it’s safe to say that they’re a respected member of the pharmaceutical GMP and compliance community. Most of FDA-regulated industry’s key events and conferences publish a list of speakers, usually with a corresponding biography.  Here is a good example from a recent FDLI conference. Take some time to browse through these sites to learn more about the potential consultant and/or the executives and practice leaders of the firms you are considering.

  1. ACTIVE IN INDUSTRY TRADE ASSOCIATIONS

Trade associations such as ISPE, PDA, FDLI, RAPS, ASQ and others are important clearinghouses for professionals to maintain currency in their knowledge and ability to solve problems.  Make sure you inquire how often the consulting firm participates with the various organizations.  There are so many different aspects and facets of pharmaceutical quality and compliance operations that good consultants need to be involved in multiple organizations just to stay current.   Active organizational participation is key when you are evaluating consulting support and problem resolution.

  1. ONLINE RESOURCES

Does the consultant your considering have helpful resources, and/or online resources that would show that they can develop tangible solutions to recurrent problems?  We always suggest perusing through any online resources provided by the consultant.  Examining offerings and solutions developed by the consultant can give you great insight into their core competencies. We’d also suggest searching for consultants by name on YouTube. If they’ve ever been a featured presenter or moderator at industry events, you can usually find the corresponding video. Being able to put a face to a name can be very reassuring. You’ll also get a glimpse into how that individual communicates, which could help you make the best decision for your organization.

  1. STANDING WITHIN YOUR PROFESSIONAL NETWORK

Your professional network is a good resource.  Experienced pharmaceutical executives have most likely worked with dozens of consultants during their career and will be happy to give you insights into specific firms or individuals. Don’t be shy about reaching out to people in your network to gather intel and references.  If you ask enough, you’ll find out which consultants are actually solving problems, and which consultants are relying on old, tired and outdated approaches to quality and compliance challenges.

  1. IN-PERSON INTERVIEW

An in-person interview is usually the best way to find out if the consultant is someone you want to work with. Be prepared to ask pointed questions.  Examples of questions you might ask include:

  • “Describe your work process? How would you work with our staff, executive management and maybe other consultants?”
  • “What strengths do you possess that will prove particularly helpful in connection with this project?”
  • “What problems do you anticipate as we begin to work together? How can we best address these problems early on?”
  • “Tell us what you already know about our company and our potential needs?” Or in other words, “Have you done any homework on our company?”

Once asked, pay attention not only to their answers – but also their personal manner and professional style.  Ask yourself and your team, did the consultant really listen to our concerns, or were they more interested in talking about themselves?  Does the consultant “get us?”  Are they in synch with our organization’s mission and organizational structure?

But remember, if you have only a small, well-defined project, a phone interview or web conference may be enough.

Bonus Tip:  Before you start your search, you can save yourself a lot of time and hassle by ensuring that your project goals are well defined. You should develop a request for proposals that clearly states the budget, time constraints and outcome you expect. This will help both you and the consultant determine whether the consultant is a good match for your organization

Filed Under: Achieving Compliance

Primary Sidebar

Sign Up To Our Newsletter

You May Also Like

Proud to be a Silver Sponsor of RIC’s Inaugural Annual Meeting! Join us March 22-23, 2023 at Convene in Arlington, VA!

Compliance Architects is proud to be Silver Sponsor of this year's RIC's inaugural annual meeting! The REMS Industry Consortium fosters collaboration and innovation to advance

Join the Team at Compliance Architects as our Content Marketing Manager!

This excellent opportunity will require the successful candidate to lead the technical content marketing and marketing automation activities as well as enable, manage, and drive
life sciences staffing

Talk to us about current talent trends, and what the industry will need in the next 5 to 10 years?

Transcript taken from 2022 PMWS by Executive Platforms The talent crisis as it has been called is certainly not something that has gone away or

Footer

Compliance Architects®

  • Contact Us
  • (888) 734-9778
  • info@compliancearchitects.com

Quick Links

  • About Us
    • Senior Staff
    • Why Us
    • Mission And Vision
    • Clients
    • Partners
    • Career Opportunities
  • Services
    • Inspection Readiness & Enforcement
      • FDA Inspection Readiness
      • Audits & Assessments
      • FDA Enforcement Response/Remediation
    • FDA Quality Consulting
      • Quality System & Compliance Turnarounds / Restructuring
      • Training / Coaching
      • Quality & Compliance Computer-Based Systems
      • External Supply Chain Compliance
      • Part 11 & Computer Systems Validation
      • Turnkey Quality Systems
    • Quality Assurance and Engineering
      • CRPN Quality Roadmap®
      • Quality Culture Assessment
      • Product Quality Consulting
      • Operational Efficiency/Compliance Effectiveness
      • Project/Program Management
    • Corporate Compliance and Litigation
      • Corporate Compliance Programs
      • Interactions With Department Of Justice And The Courts
    • FDA Regulatory Consultants
      • Product Development / Submissions / Commercialization
      • REMS (Risk Evaluation And Mitigation Strategies)
      • Mergers / Acquisitions / Licensing
    • Quality, Compliance, Regulatory & Operations’ Staffing
      • Staffing
      • Talent Management
      • Rapid Turnaround
  • Innovative Solutions
    • Writing for Compliance®
    • CRPN Quality Roadmap®
    • Quality Pulse®
    • IEEP
    • REMS
  • Success Stories
  • Industries
    • Biopharmaceuticals
    • Cannabis/CBD
    • Cell & Gene Therapies
    • Combination Products
    • Cosmetics
    • Dietary Supplements
    • Medical Devices and Diagnostics
    • Pharmaceuticals
  • Contact Us

Our Services

  • Inspection Readiness & Enforcement
  • FDA Quality Consulting – Systems and Training
  • Quality Assurance and Engineering
  • Corporate Compliance and Litigation Services
  • FDA Regulatory Consultants – Due Diligence
  • Quality, Compliance, Regulatory & Operations’ Staffing Services

Proprietary Solutions

  • Writing for Compliance®
  • Quality Pulse®
  • CRPN Quality Roadmap®

© 2009-2023 Compliance Architects Holdings LLC – used by permission. All copyrights, trademarks and other intellectual property are the property of Compliance Architects Holdings LLC and are used by permission.

  • Debarment Certification Statement
  • Privacy Policy
  • Terms of Use

Contact Us Today

We use cookies on our website to give you the most relevant experience by remembering your preferences and repeat visits. By clicking “Accept”, you consent to the use of ALL the cookies.
Do not sell my personal information.
Cookie SettingsAccept
Manage consent

Privacy Overview

This website uses cookies to improve your experience while you navigate through the website. Out of these, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may affect your browsing experience.
Necessary
Always Enabled
Necessary cookies are absolutely essential for the website to function properly. These cookies ensure basic functionalities and security features of the website, anonymously.
CookieDurationDescription
cookielawinfo-checkbox-analytics11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Analytics".
cookielawinfo-checkbox-analytics11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Analytics".
cookielawinfo-checkbox-functional11 monthsThe cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional".
cookielawinfo-checkbox-functional11 monthsThe cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional".
cookielawinfo-checkbox-necessary11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookies is used to store the user consent for the cookies in the category "Necessary".
cookielawinfo-checkbox-others11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Other.
cookielawinfo-checkbox-performance11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Performance".
viewed_cookie_policy11 monthsThe cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data.
Functional
Functional cookies help to perform certain functionalities like sharing the content of the website on social media platforms, collect feedbacks, and other third-party features.
Performance
Performance cookies are used to understand and analyze the key performance indexes of the website which helps in delivering a better user experience for the visitors.
Analytics
Analytical cookies are used to understand how visitors interact with the website. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc.
Advertisement
Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. These cookies track visitors across websites and collect information to provide customized ads.
Others
Other uncategorized cookies are those that are being analyzed and have not been classified into a category as yet.
SAVE & ACCEPT