TwitterLinkedin

Contact Us

  • News & Events
    • News
    • Webinars
    • Events
  • Resource Library
    • Thought Leadership
    • Fact Flyers
    • Case Studies
    • White Papers
    • Webinars
    • Infographics
    • Video & Animation
  • Careers
    • Working at PharmaLex
    • Your Application Process
    • Current Opportunities
  • Training
Top Bar
Search
PharmaLex Logo
MENUMENU
  • PharmaLex Logo
  • PharmaLex Logo
  • About UsAbout Us
    • About Us
    • Management Team
    • Our Milestones
    • Corporate Social Responsibility
    • What Our Clients Say About Us
  • Our Services
    • Discovery / Non-clinical
          • Go to Discovery / Non-clinical section >>

          • Strategy and Consulting

            • Development Strategy and Gap Analysis
            • Integrated Product Development
            • Market Access Strategy
            • Non-clinical Development Concept
              and Study Design
            • Scientific Advice
            • Scientific Due Diligence
            • Statistical Services
            • Toxicology Services
    • Clinical Development
          • Go to Clinical Development section >>

          • Strategy and Consulting

            • Clinical Program Development
            • Orphan Drug Designation
            • Pediatric Investigation Plan (PIP)
            • Scientific Advice
            • Statistical Services
          • Regulatory Affairs

            • Clinical Trial Applications (CTA)
            • Global Procedure Management
            • Health Authority / Agency Interaction
            • Regulatory Operations
          • Pharmacovigilance

            • Clinical Trial Safety Support
            • Pharmacovigilance Consulting
          • Quality

            • GxP Services
            • IMP Management
            • Interim / Contract QA
            • Quality Systems
            • Tech Transfer / Scale-up
            • Vendor Management and Oversight
    • Authorization / Approval
          • Go to Authorization / Approval section >>

          • Strategy and Consulting

            • Market Access
          • Regulatory Affairs

            • CMC Services
            • Global Procedure Management
            • Health Authority / Agency Interaction
            • Marketing and Labeling Activities
            • Regulatory Operations
            • Scientific, Regulatory and Technical Writing
            • Statistical Services
          • Pharmacovigilance

            • EU QPPV / National QPPV
            • Pharmacovigilance Consulting
          • Quality

            • Commercialization Readiness
            • Commissioning, Qualification, and Validation (CQV)
            • GxP Services
            • Interim / Contract QA
            • PAI Readiness
    • Post-approval / Maintenance
          • Go to Post-approval / Maintenance section >>

          • Strategy and Consulting

            • Environmental Risk Assessment
            • Market Access
          • Regulatory Affairs

            • CMC Services
            • Global End-to-End Outsourcing
            • Global Procedure Management
            • Health Authority / Agency Interaction
            • Marketing and Labeling Activities
            • Mergers and Acquisitions (M&A) Transfers
            • Regulatory Operations
            • Toxicology Services
          • Pharmacovigilance

            • Audit and CAPA Management
            • EU QPPV / National QPPV
            • ICSR Management
            • Literature Screening
            • Pharmacovigilance Systems
            • Safety Writing (PSUR, RMP)
            • Signal Management
          • Quality

            • Commissioning, Qualification, and Validation (CQV)
            • Good Distribution Practice (GDP) Compliance
            • GxP Services
            • Interim / Contract QA
            • Quality Systems
            • Vendor Audit
            • Vendor Management and Oversight
          • Medical Affairs

            • Healthcare Compliance and Medical Approval
            • Medical Information
    • Program Management
          • Go to Program Management section >>

          • Program Management

            • Global End-to-End Outsourcing
            • Global Procedure Management
            • Integrated Product Development
            • Mergers and Acquisitions (M&A) Transfers
    • Featured Expertise
          • Industry Expertise

            • Biopharmaceuticals
            • Consulting
            • Consumer Healthcare
            • Generics
            • Herbal Medicines
            • Medicinal Products
            • MedTech Services
            • Pharmaceutical
            • Veterinary Drugs
          • Service Expertise

            • ATMP / Cell and Gene Therapy
            • Brexit
            • COVID-19 Support
            • Drug Re-purposing / Value-added Medicines
            • GxP Services
            • Market Access
            • Pharmacovigilance Consulting
            • Statistical Services
            • SMARTPHLEX - technology-enabled services
  • Global ReachGlobal Reach
  • Contact usContact us
  • News & Events
    • News
    • Webinars
    • Events
  • Resource Library
    • Thought Leadership
    • Fact Flyers
    • Case Studies
    • White Papers
    • Webinars
    • Infographics
    • Video & Animation
  • Careers
    • Working at PharmaLex
    • Your Application Process
    • Career Opportunities
  • Training
Home > News & Events > Ireland > Technical Helpdesk Service

Technical Helpdesk Service

In the current challenging and competitive pharmaceutical and life science industries, it is imperative that companies overcome any obstacles they encounter as quickly as possible in a manner that is effective, conforms with quality and compliance regulations and does not impact product safety.

At PharmaLex, we have developed a Technical Helpdesk service to allow our clients quick and easy access to regulatory compliance information and support provided by our team of experts. The support can be provided via email,  phone or an on site visit.

How does the Helpdesk Work?

For greater flexibility the help desk operates using pre-purchased credits. Once PharmaLex receives your technical query via email or phone,  we will agree the number of credits that will be used to provide you with a written response and a timeline for delivery. For each Technical Query, PharmaLex will respond with a comprehensive documented response in compliance with current legislation and best practice standards.

What types of Queries can be covered by our Helpdesk?

The Helpdesk can to provide answers to a wide range of technical queries covering all areas including but not limited to;

  • Good Manufacturing Practice (GMP)
  • Good Distribution Practice (GDP)
  • Good Pharmacovigilance Practice (GVP)
  • Good Clinical Practices (GLP)
  • Medical Device Regulations
  • Investigational Medicinal Products (IMP)
  • Marketing Authorisation Holder (MAH) compliance
  • Promotion and Advertising
  • Current Best Practice – various topics
  • Interpretation of Legislation e.g. FMD
  • Opinion on specific scenarios
  • Review of Investigation Reports, Draft QTAs, etc.
  • Batch specific quality queries
  • Quality Risk Management (QMR)
  • Computer System Validation (CSV)

 

What are the Benefits to the Technical Helpdesk?

  • Ready access to a team of international consultants, including several former EU and US Regulators, with expertise across the entire product lifecycle
  • Input from SMEs as required
  • Independent assessment and expertise to support client’s own expertise
  • Leverage specific expertise and consultant team knowledge of current best practice and Regulatory expectations.
  • Having pre purchased credits allows for a faster response time (as the PO is already in place) with solutions provided.
  • PharmaLex will provide the estimated consultancy hours required to the client when the initial query is received, and the actual consultancy hours will be invoiced when query is resolved allowing for complete transparency for the client.
  • Service can be used by different departments within the same company

 

For more information on our Technical Helpdesk, or any other services that PharmaLex provide, why not get in touch by connecting with us on +353 1 846 4742 or email us at contactirl@pharmalex.com.

Related posts
fda webinar
What you need to know to submit Study Data to FDA
19th January 2021
SMARTRISK
SMARTRISK – risk assessment excipient tool
12th January 2021
medical devices digital health era
Medical Devices in the Digital Health Era
10th December 2020
medicinal cannabis
Medicinal Cannabis: The Wonder Substance
1st December 2020
Regulatory Challenges in the COVID Era
1st December 2020
Biopharma Excellence
PharmaLex creates specialized biopharma service line
20th October 2020
Search
Upcoming Webinars

January 26th, 2021

Unlocking BLA, NDA, IND Submissions

5 PM CET

February 2nd, 2021

Central American Regulation for Drug Products (LATAM)

3 PM CET

February 25th, 2021

What you need to know to submit Study Data to FDA

5PM CET

Upcoming Events

March 22 - January 25th, 2021

BIO Europe 2021

March 15 - 19th, 2021

DIA Europe 2021

June 27 - July 1st, 2021

DIA Annual Meeting 2021

September 22 - 24th, 2021

TOPRA Symposium 2021

Categories
  • All News
  • Webinars
  • Events
Archive
USEFUL LINKS
  • Home
  • Contact us
  • Imprint
  • Data Protection
  • Terms and Conditions
RECENT TWEETS
Tweets by @PharmaLexGLOBAL
COVID-19 NEWSLETTER SIGN UP

SIGN UP NOW

WHAT OUR CLIENTS SAY
  • I just wanted to let you know that the recent EU Codes webinar was excellent. Rina presented a very complex and grey topic in the most clear and digestible manner – a sign of a true expert. The questions in the Q&A were sometimes a little ambiguous but Rina gave clear and relevant answers that provided real clarity.

    Richard Blackwell
    Medical Team Leader, Multi Tumor Franchise Roche Products Ltd
PharmaLex
©2021 PharmaLex GmbH. All rights reserved.

ISO9001:2015 LogoEnergie Audit Logo

#AskTheExpert #TogetherBEYONDCOVID19





    Select your state:

    .
    You can unsubscribe at any time at data.protection@pharmalex.com

    If you do not wish to receive any communication from us, you can unsubscribe at any time at. Click here to view our Privacy Policy.

    #TogetherBEYONDCOVID19

    We closely monitor developments and updates surrounding the current outbreak of Coronavirus Disease 2019 (COVID-19) from official sources including the World Health Organisation and are following the guidance and direction of the governments and the local authorities. We are taking this situation very seriously and our number one priority is the safety and business continuity for our customers and colleagues. As ever, we will do everything we can to ensure that services are delivered within the required time and the trusted quality PharmaLex is known for

      Please DO NOT send us event/conference information.
      We will not respond and these will be deleted immediately.





      Select your state:

      .
      You can unsubscribe at any time at
      data.protection@pharmalex.com

      If you do not wish to receive any communication from us, you can unsubscribe at any time at. Click here to view our Privacy Policy.

      Privacy Policy

      This can be specific information about signing up to the newsletter.

      Pellentesque lobortis, tellus at ultrices ullamcorper, lectus tellus consectetur lectus, id consequat leo quam quis eros. Mauris pellentesque tortor a augue pellentesque ultricies. Phasellus sit amet suscipit orci, vel dapibus ligula. Maecenas at pellentesque lectus, sit amet tristique felis. Integer fringilla risus ac neque mollis, at imperdiet lacus sodales. In vehicula orci sed vulputate interdum. Nunc sagittis non nunc eget sollicitudin.

      Maecenas a mattis erat. Phasellus cursus erat non nisl pulvinar ultricies. Aenean id fringilla libero. Orci varius natoque penatibus et magnis dis parturient montes, nascetur ridiculus mus. Morbi in ultrices elit. Suspendisse egestas hendrerit est. Integer pellentesque nisl ut justo tempus, nec suscipit dolor luctus. Cras vestibulum elementum tincidunt.

      In compliance with the Spanish Law 15/1999, of Protection of Personal Data and in accordance with regulations approved by the Spanish RD 994/1999 inform you that your data will be part of a file located in Friedrichsdorf (Germany), whose ownership belongs to Pharmalex Spain S.L.U. The purpose of these data is the insertion in a potential job selection process. Inform the user that at any time may exercise their right of access, rectification, and deletion of data through email curriculum@pharmalex.com or to this postal address Pharmalex Spain. Coso 103, 50001 Zaragoza, Spain.