Audits & other support

 

Support in pharmacovigilance, regulatory affairs and medicinal aspects cover services as GVP and GCP audits, vendor audits, preparation for pharmacovigilance inspections, support of a drug safety physician, medical and scientific writing services, safety in clinical trials and the common technical document as well as pharmacovigilance training courses.

Also in cases of sudden work overload Lindeq supports with respective services.

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Pharmacovigilance audits are a requirement described in the GVP and GCP, providing a snapshot of the established processes and compliance of given policies, plans, procedures, regulations and contracts.

 

Lindeq has many years of experience in conducting both GVP as well as GCP safety audits and has also participated in various inspections conducted by different Competent Authorities (CA).

 

As a third party provider Lindeq provides an objective evaluation which also prepares for possible upcoming CA inspections.

 

Linder provides:

 

Audits of selected processes and tasks, as e.g.

  • Selected responsibilities and procedures for PV

  • Literature Screening

  • Processing and Submission of Individual Cases

  • Periodic Safety Reporting (PSUR, DSUR...)

  • Signal Detection and Management

  • Core Safety Information

  • Maintenance of Product Information

  • Risk Management / Pharmacovigilance Planning

  • Training

  • Quality Management Systems

  • Management of Safety related Processes in Clinical Trials

 

 

Complete system audits   

  • Audit Plan and agenda: defines scope of audit and timelines for the audit processes

  • Audit Conduct:

opening meeting

interview of respective employees

review of associated documents and processes

closing meeting

  • Audit Report:

summary of covered topics including detailed description of detected issues

classification of these and respective proposed action(s)

  • Post Audit: Lindeq can assist and support with resolving audit findings

 

For more detailed information please contact us directly. Together we will find the best solutions to fit your individual needs.

 



A notice of inspection can cause additional strain and workload. To assist you, we can perform an audit in order to minimise inspection findings. Furthermore, we can train your staff on how to behave during an inspection which, combined with a 'mock-inspection', can be a helpful instrument ensuring subsequent inspections without critical findings.

For more detailed information please contact us directly. Together we will find the best solutions to fit your individual needs.



In order to protect patients the risk-benefit balance of your product has to be assessed continuously. All available sources of information have to be considered and this can be a complex task. Profound knowledge is required to analyse all sources of information that could affect the risk-benefit balance.

Our pharmacovigilance experts provide comprehensive risk-benefit assessments. If the risk-benefit balance has changed, Lindeq will support you in terms of updating the relevant Risk Management Plan and related documents.

For more detailed information please contact us directly. Together we will find the best solutions to fit your individual needs.



Lindeq can provide 24/7 access to one of our physicians who assume the role as a medically qualified person in case your QPPV is not a physician. There are various reasons why medical advice would be of advantage, such as questions regarding the assessments of a newly received AE, a second opinion of a medical issue, etc.

For more detailed information please contact us directly. Together we will find the best solutions to fit to your individual needs.



The Lindeq Medical Writing Services are provided by a team with broad knowledge from documentation in pharmaceutical industry and academic research including pharmacovigilance experts, scientists, pharmacists, pharmacologists, preclinical experts, toxicologists and physicians with clinical expertise.

Our team has extensive medical writing experience including preparation of all types of pharmacovigilance documentation, CTD documentation, investigators brochure, study protocols and amendments, study reports and amendments, manuscripts for publication in high rated journals, literature reviews, congress abstracts and poster presentations.   

Our dedicated experts prepare clear and concisely worded documents, precisely customised to the required documentation and individual pharmaceutical product.

For more information please contact us.



The Clinical Overview is intended to provide a critical analysis of the clinical data in the Common Technical Document (CTD). Lindeq has an experienced team of physicians, scientists and external experts that can prepare the expert statement for the Clinical Overview in the CTD.

The designated experts will present the strengths and limitations of the study results and development program, analyse the risks and the benefits of the product in its intended use, and describe how the study results support critical parts of the prescribing information.

 

The Clinical Summary is intended to provide a detailed, factual summarisation of all of the clinical information in the CTD. The Lindeq team of physicians and scientists will compare and analyse the result across studies based on the factual observations.

 

For more information please contact us directly.



The Nonclinical Overview should present an integrated and critical assessment of the pharmacologic, pharmacokinetic, and toxicology of the pharmaceutical product. Lindeq has an experienced team of scientists including toxicologists, pharmacologists and physicians that can prepare the Nonclinical Overview for the Common Technical Document (CTD).

Our designated experts will provide an integrated and critical assessment of the pharmacology, pharmacokinetic and toxicology of the medicinal product.

 

The nonclinical written and tabulated summary is intended to provide a comprehensive, factual synopsis of the nonclinical data. The Lindeq team of toxicologists, pharmacologists and physicians will compare and analyse the result across studies based on the factual observations.

 

For more information please contact us directly.



Our pharmacovigilance team also includes experienced physicians within different clinical disciplines. In addition to tasks such as assessment of risk-benefit or medical reviews, we can also support you with general medical consultancy.

For more detailed information please contact us directly. Together we will find the best solutions to fit your individual needs.



Evolving pharmacovigilance regulations demands a high level of attention and profound knowledge for any pharmacovigilance professional. A continuous training scheme is an essential component to meet and fulfil the various requirements. Lindeq is your competent partner, providing up-to date and comprehensive training.

From risk management and aggregated reports to MedDRA® coding and regulatory requirements, we offer tailor made programs within all aspects of pharmacovigilance and drug safety, from basic to advanced level, from individual training to sessions for the entire department. Regardless whether it is for your dedicated pharmacovigilance staff or sale representatives, we tailor your training. With several years of experience teaching pharmacovigilance Lindeq will ensure you are in the best hands.

Lindeq also provides training to prepare your department adequately prior to an inspection. Click here for further information.

For more detailed information please contact us directly. Together we will find the best solutions to fit your individual needs.



In case of sudden work overload or limited amount of employees due to holiday time, maternity leave, sickness, etc., Lindeq can provide experienced staff and support within all kind of pharmacovigilance tasks.

Together we will decide on the best way to proceed. Thanks to our vast experience, we immediately understand our client's needs and are able to commence with the given tasks as quickly as possible. The Lindeq team, which consists of medical doctors, scientists, pharmacists and pharmacovigilance experts with clinical experience from the pharmaceutical industry and as drug safety consultants, will always find a satisfying solution, ensuring high quality results.

For more detailed information please contact us directly. Together we will find the best solutions to fit your individual needs. 



Within the EU and EEA most safety data is processed in English. However, sometimes reported data such as spontaneous cases might be reported in the language of the respective country which the data derives from. This also includes local literature.

In case any difficulties arise due to data being received in a foreign language, Lindeq can help you, in most cases, on short notice. The pharmacovigilance team at Lindeq consists of people with various native language skills. Besides all Scandinavian languages this also includes Dutch, Finnish, French, German, Greek, Hindu, Italian, Lithuanian, Portuguese, Russian, Spanish, and Tamil.

We are used to handle pharmacovigilance related information in both English and the respective foreign language and are happy to help you, regardless if it is one single case or a larger amount of data.

For more detailed information please contact us directly. Together we will find the best solutions to fit your individual needs. 






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ICSR management, EudraVigilance, RMP, CCSI, PSUR, DSUR, Signal management, XEVMPD, and many more.
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Medical Device Vigilance
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PQ validations, data migrating and mapping, safety database software, EMA gateway testing
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