Our Services

Full-Service Pharmacovigilance

Panacea has been a leading supplier of pharmacovigilance services since 2009 and we offer a comprehensive suite of fully compliant pharmacovigilance services which we have continuously refined to ensure that they are as effective and efficient as possible.

Our team of experienced pharmacovigilance experts and in-house safety physicians will provide you with a high quality service that you can rely on, and we will ensure that you meet all your pharmacovigilance obligations according to the latest regulations and guidance.

Whether you are a relatively small MA holder with one product in a single country, or a large multinational with numerous marketed products that create high case volumes requiring 24/7 support, we have the capability to scale our services to suit your needs.

Panacea can set-up and maintain your full pharmacovigilance system and can take care of all the pharmacovigilance activities required to support your Marketing Authorisations, including preparation of all pharmacovigilance documentation, provision of QPPVs, literature searching, signal detection, medical information services, and full case processing using our fully validated and industry-leading Argus database.

At Panacea we pride ourselves on our flexible approach and we can work with you to create a bespoke solution that is specific to your requirements and products.

So why not discover how Panacea can provide you with a total solution to all your pharmacovigilance needs?

To discuss your pharmacovigilance requirements and how Panacea can support you, please email us on bd@panacea.im or call us on +44 1624 672777.

Alternatively, you can request a proposal using our online contact form:

Request a proposal

Ad hoc Pharmacovigilance Support

If you manage your own pharmacovigilance system but require support with specific activities then Panacea would be delighted to help.

We offer a comprehensive range of fully compliant pharmacovigilance services and we can provide these as standalone activities or combined as required to meet your needs.

At Panacea, we pride ourselves on our flexible approach and we are happy to work with you to create a bespoke solution that is specific to your requirements and products.

Our ad hoc pharmacovigilance support can be provided as a short-term solution to assist you with an urgent need, or you can outsource activities to us on a long-term basis.

Whether you are interested in a single service, or a bespoke combination of services, just tell us what you want and our team of experienced pharmacovigilance experts will create a solution that is exactly tailored to your needs, ensuring that you meet all of your obligations according to the latest regulations and guidance.

To discuss your pharmacovigilance requirements and how Panacea can support you, please email us on bd@panacea.im or call us on +44 1624 672777.

Alternatively, you can request a proposal using our online contact form:

Request a proposal

Regulatory Affairs

Panacea’s team of experts in regulatory affairs have extensive experience and can provide high-quality and efficient regulatory support. 

We can devise bespoke solutions to meet all of your regulatory affairs needs, from ad hoc support for urgent projects through to long-term provision of full regulatory services.

Panacea can help you to develop your regulatory strategies, perform dossier audits and gap analyses on your behalf, prepare, submit and manage your MA applications, and provide full lifecycle maintenance for your products.

We are expert in eCTD publishing and are happy to offer this as a standalone service if required.

So why not get in touch?

To discuss your regulatory requirements and how Panacea can support you, please email our Regulatory Affairs team on RA@panacea.im or call us on +44 1624 672777.

Alternatively, you can request a proposal using our online contact form:

Request a proposal

Clinical Trial Pharmacovigilance

Whether it is case intake, processing, submission, or reporting and analysis, at Panacea we have a wealth of experience to ensure that you meet your obligations as a sponsor organisation with regard to the safety evaluation of Investigatory Medicinal Products (IMPs).

Our flexible approach means that we can work with you to create a bespoke model that exactly suits your needs.

Our robust systems ensure compliant performance of required activities and timely communication of relevant information to all concerned parties including investigators, Competent Authorities and Institutional Review Boards/Ethics Committees.

Key services:

  • Full case processing / reporting
  • Aggregate / Periodic report writing, including IND, DSUR, etc.
  • Reconciliations with the clinical databases
  • Fully validated industry-leading pharmacovigilance database (Argus)
  • Risk Evaluation
  • Consultation / advice on study protocols, Serious Adverse Event (SAE) forms etc.
  • Post-marketing clinical trial services
  • Development of Safety Management Plans

To discuss you clinical trial pharmacovigilance requirements and how Panacea can support you, please email us on bd@panacea.im or call us on +44 1624 672777.

Alternatively, you can request a proposal using our online contact form:

Request a proposal

EU & Local QPPV

Panacea has recently established a ‘QPPV Office’ to co-ordinate our international QPPV services. Our in-house experts working within this team assist our EU QPPVs and are also responsible for managing our trusted local pharmacovigilance partners within Europe and around the globe.

EU QPPVs

Panacea has a team of EU QPPVs who have been carefully selected for their experience and key attributes.

We can provide an EU QPPV & Deputy as part of a pharmacovigilance package or as a standalone service if needed. We have an office at Dublin airport that serves as a convenient meeting place and can be used to host audits and authority inspections if required.

Local PV personnel in EU/EEA

Panacea has extensive experience and knowledge of local pharmacovigilance requirements in the EU/EEA, and we know exactly what is expected in each territory.

Using our established network of audited partners, we can provide local pharmacovigilance services across Europe. These services include nomination of Local Qualified Person for Pharmacovigilance (LQPPV) or Local Contact Person for Pharmacovigilance (LCPPV), monitoring of local literature and of local authority websites, and all other local pharmacovigilance activities that may be required in a specific country.

UK post-Brexit requirements

With several experienced QPPVs based in the UK and with an office conveniently situated near London, Panacea can assist with all UK pharmacovigilance requirements.

Global pharmacovigilance network

LQPPVs and LCPPVs are becoming an increasingly common regulatory requirement and/or expectation outside of Europe. At Panacea we understand this and we stay up to date with all the different requirements worldwide.

With our in-house experts and our network of trusted international partners, we are able to provide local pharmacovigilance services in countries around the globe.

To discuss your requirements and how Panacea can support you, please email our QPPV office using QPPV@panacea.im or call us on +44 1624 672777.

Alternatively, you can request a proposal using our online contact form:

Request a proposal

Training

Pharmacovigilance Training

According to Good Pharmacovigilance Practice, all personnel involved in the performance of pharmacovigilance activities should receive initial and continued training.

For Marketing Authorisation holders, this training should relate to the roles and responsibilities of personnel to ensure that they have a full understanding of relevant pharmacovigilance requirements.

Adequate training should also be considered for those staff members to whom no specific pharmacovigilance tasks and responsibilities have been assigned but whose activities may have an impact on the pharmacovigilance system or the conduct of pharmacovigilance.

In addition, all staff members should receive and be able to seek information about what to do if they become aware of a product safety concern.

Whether you require annual or ad hoc pharmacovigilance training, Panacea can provide a bespoke solution to meet your needs. Our training can cover general pharmacovigilance, or it can be focused on an individual area, and we will ensure that you get the knowledge and outcome that you seek.

Inspection-readiness Training

Panacea’s Quality function has extensive first-hand experience of Regulatory Authority inspections, and we utilise this experience to provide inspection-readiness training.

This training would be tailored to your needs but can include intensive courses on relevant regulations, advice on inspection activities, and one-to-one training on interview techniques for your inspector-facing employees.

To discuss your training requirements and how Panacea can support you, please email our QA team using PanaceaQA@panacea.im or call us on +44 1624 672777.

Alternatively, you can request a proposal using our online contact form:

Request a proposal

Quality Assurance

The Quality Management System (QMS) underpins the pharmacovigilance system and, as such, a good QMS is critical to ensure that compliance with relevant legislation is maintained.

Panacea’s Quality Assurance team have extensive experience working with QMS systems, including within large multi-national pharma companies, and we offer a full range of Quality services.

We can conduct a review and gap analysis of your existing QMS to identify areas for improvement, or we can work with you to prepare and implement an entire suite of procedures. We can also help you to develop and monitor essential pharmacovigilance performance measures and to identify areas that need attention.

A QMS ‘health check’ conducted prior to an audit or inspection is something we have done for many clients and that we highly recommend in order to ensure that any gaps can be closed in advance.

Following an audit or inspection, Panacea’s expert team can support you with the creation, implementation and closure of Corrective & Preventative Actions (CAPAs). We are very experienced in both the preparation and management of CAPA response documents and, whether CAPAs stem from a routine audit or from a Regulatory Authority inspection, our team will work tirelessly on your behalf.

Third Party, Vendor & Risk Management

The management of third parties and vendors is a continually changing environment for all companies and Panacea can help you to mitigate any potential risks by taking care of ongoing compliance checks.  We have a number of practical solutions to support you with this, which include writing due diligence risk questionnaires, conducting independent due diligence audits, and assessing third party risk in order to enable strategic planning of upcoming audits.

Maintenance and Management of Pharmacovigilance Agreements (PVAs) / Safety Data Exchange Agreements (SDEAs)

Panacea currently manages and maintains the PVAs/SDEAs for clients of all sizes. We can use our own in-house management tools and procedures, or work with your tools, systems and in-house procedures as required. We pride ourselves on our flexible approach and we will gladly develop a bespoke way of working to suit your needs.

To discuss your QA requirements and how Panacea can support you, please email our QA team using PanaceaQA@panacea.im or call us on +44 1624 672777.

Alternatively, you can request a proposal using our online contact form:

Request a proposal

Auditing

Independent audits are an essential component of any pharmaceutical company’s Quality Management System (QMS). If conducted well, an audit will provide an unbiased opinion of the operational performance of the QMS, measured against its own procedures and regulatory requirements.

Whether it is a one-off audit or the management of your full audit program, Panacea will provide a professional and reliable service that you can trust.

Our team of highly qualified auditors operate globally, and all have in excess of 10 years’ industry experience. They are friendly, flexible, and always keen to share their knowledge.

You can be assured that Panacea’s auditing team will work in partnership with you. We enjoy helping organisations to attain and maintain compliance and many of our clients ask us to manage their entire audit ‘universe’, including preparation of their audit strategy and full management of their audit schedule.

Although full audits are best conducted on-site, we can conduct them remotely when this is appropriate and feasible.

We can also prepare and conduct ‘desktop audits’ when this is the most suitable auditing option.

Audit Types

  • GVP/GCP audits
  • Full PV system audits
  • Third party compliance audits (e.g. distributors, service providers, vendors)
  • CRO/PV service provider audits
  • Medical Information audits
  • Regulatory audits

Additional Auditing Services

  • Preparation of risk assessment questionnaires
  • Preparation of remote audit feasibility questionnaires

To discuss your auditing requirements and how Panacea can support you, please email our QA team using PanaceaQA@panacea.im or call us on +44 1624 672777.

Alternatively, you can request a proposal using our online contact form:

Request a proposal

Global Literature

Published medical and scientific literature is a valuable source of safety information relating to medicinal products, which is why global literature monitoring is an essential part of all pharmacovigilance systems.

Within the EU and in many other territories, MA holders are required to perform regular screening of the global literature in order to identify reportable adverse events known as Individual Case Safety Reports (ICSRs), and to detect new signals for emerging safety issues.

Many companies choose to outsource their literature monitoring activities and at Panacea we have considerable experience and expertise in this area.

When undertaking this activity on your behalf, we will develop robust search strategies specifically for your product portfolio and use the large bibliographical databases of Embase® to search the global indexed literature for ICSRs, published studies and other relevant safety information. Depending on your requirements, we can then review, assess and document the search results for use in signal detection and aggregate reports.

The EU Medical Literature Monitoring (MLM) service

The European Medicines Agency (EMA) operates a Medical Literature Monitoring (MLM) service that screens global literature for adverse events associated with certain products authorised in the EU, and the results of this screening (which is available via EudraVigilance) must be monitored by the MA holders of products containing an active substance included on the MLM list.

As part of our literature monitoring service, Panacea can monitor and review the MLM results on EudraVigilance for relevant ICSRs that have been identified.

Local Literature Monitoring

Monitoring of relevant local, non-indexed scientific and medical literature is a requirement throughout Europe and in many countries around the world for marketed products.

Using our existing international network of pharmacovigilance partners, we can arrange screening of the local literature in all European countries and around the world to identify ICSRs and other relevant safety information.

To discuss your literature requirements and how Panacea can support you, please email our Data Evaluation team using evaluation@panacea.im or call us on +44 1624 672777.

Alternatively, you can request a proposal using our online contact form:

Request a proposal