The Overview

The department for Pharmacovigilance offers a comprehensive suite based on outsourced services. This ensures the compliance for a wide range of different products.

The operational team and QPPVs offer the utmost protection for the safety of your data. We also assist our customers to manage and comply with their prior commitments. This also involves monitoring the safety of the patient.

Our fully functional and standard industry database offers maximum flexibility to our clients operating on a small scale. We also extend our expertise to those global multinationals that need our support 24/7 regarding the high volumes of their marketed products.

Post Marketing Help

The professionals working for us extend their complete support and help for products involving generics, advanced therapies and innovator products. Our team of professionals and QPPVs can offer a plethora of medical care needs to a wide variety of product collections.

Our services include the following.

QPPV Services.
24-hour Pharmacovigilance cover.
We extend our expertise to the companies in Europe, without being formally present in Ireland and the United Kingdom.
Every medical information
Automated electronic management of event reports on adverse cases
Literature Search and Reviews
Signal Detection
Periodic Safety Reports or PSURs
Setting up and monitoring the EudraVigilance.
Risk Management Plan writing. (RMP)

Apart from all of this the client also receives auditing services for PV systems along with PV training.

All about Clinical Trials and Speciality

To safeguard the patient's safety, it is essential to evaluate the clinical settings that are required for the complete Pharmacovigilance coverage. It is done to encounter the requirements of the Sponsor. The experienced professionals that we are specialized in offering PV resolutions for the thought-provoking clinical programmes.

They offer the services mentioned below:

Taking the necessary steps and reporting to the Ethics Committees, investigator sites and Competent Authorities in case of adverse events.
Global Drug Safety Project Management.
Electronic Expedited Reporting or EudraVigilance.
Setting up and oversight of EudraVigilance.
Management of Pharmacovigilance for global clinical development programmes.
Preparation of the DSURs and distributing them.
Electronic Management of the database regarding Adverse Event Reports.

We also possess the expertise required to handle the reporting necessities of Advanced Therapies utilising a broad understanding of the niche zone.

Medical Device Vigilance

There have been some significant and promising changes in the field of medical devices. However, our competent team can offer you a unique solution regarding your medical maneuver vigilance programme.

It offers the services listed below:

Collecting the required data on all the medical device related incidents along with taking necessary steps for the follow-up procedures.
Project Management for medical devices.
Distributing the notices related to field safety and its corrective actions
Submitting Medline’s weekly literature searches
Proper electronic management of the incidents.

Auditing, training, and PV Systems

The team goes through pharmacovigilance departments’ performance and makes sure everything is according to the set guidelines and regulations. After thorough assessment, it offers detailed methods to improve the functioning of the pharmacovigilance departments.

These are the services we offer:

Proper planning and pre-inspection preparation.
Monitoring the performance of the PV departments through the provision of audits.
Following the procedural gap analysis and offering provisions regarding the recommendations for continual improvement
Staff training
Quality systems review.

Clinical Trial

Clinical Trial Stage PV Support

A proper balance is required between the need to establish an active and fully functioning compliance programme for monitoring safety while adjusting with the changing nature of the development programmes.

Sunshine Consultancy offers the required services to meet the demands of the smallest Phase I study along with the complex multi-centre and global clinical trials. We possess the experience needed for tests that involve a broad range of indications and product types that include advanced therapies.

Our other services include:

Drug Safety Project Management
Collection of data and following up on the procedures of SAEs or Serious Adverse Events.
Responsible Person for Eudravigilance oversight
Electronic management of SAEs on the database
Reporting to the Ethics Committees faster and in a more accomplishes manner.
Expedited reporting to Competent Authorities
Set up and management of EudraVigilance
Reconciliation with clinical database
Reporting to the Ethics Committees and Competent Authorities after every six months or on a quarterly basis.
Compliance review and oversight
24/7 customer support
Signal Detection

Named Patient and Compassionate Use Programme

We offer monitoring and other pharmacovigilance services for the named patient

Some of the specialist services offered are as follows.

Filing and Archiving
Collecting data and following up on the required procedures of AEs or Adverse Events. This will take place via the use of compassionate use programs.
Oversight of the QPPV and the deputy QPPV
Weekly literature searches of Medline
Managing the Drug Safety Project with efficiency
Electronic expedited reporting to Health Authorities
Automated management of AEs on the database
Compliance oversight
Eudravigilance set-up and management
24-hour cover

Post Marketing

Post Market Pharmacovigilance Support

We take great pride in announcing that our clients are of a diverse range. From small-scale generic companies to large-scale operations performed by multinational organisations - we do it all. Our pharmacovigilance department has established its place in the PV services market for its flexibility regarding the full range of services it offers. It also has the potential to handle large case volumes.

The services we offer include

QPPV services
A wide range of products comprising of innovator products, generics, and advanced therapies.
Full range of products including generics, innovator products, advanced treatments
Despite our absence in UK & Ireland, we offer our uncompromised support to EU.
Periodic Safety Reports (PSURs)
24x7 Pharmacovigilance cover
EudraVigilance set up and oversight
Electronic expedited reporting (EudraVigilance)
Risk Management Plan (RMP) writing
Medical Information service
Signal detection
Adverse Event reports are managed electronically and stored on the database
PV training.
Literature Search and Reviews
Auditing of PV systems

Post Market Medical Information

Our impeccable customer support offers round the clock services. From taking care of enquiries to handling the receipts, logging and follow up of different medical information, Sunshine Consultancy Medical Information Hotline offers it all.

Medical Device Vigilance

The massive changes in the regulatory landscape of medical devices are hard to overlook. However, our team has the potential to offer robust solutions regarding medical vigilance programmes and also provides the following services.

Collection and follow-up of Medical Device Incidents
Device Vigilance Project Management
Weekly literature searches of Medline
Proper reporting of Incidents related to medical devices to the Competent Authorities
Automatic Recording of the incidents.
Distributing notices regarding the Corrective Actions and the Field Safety.

Auditing and Inspections.

Sunshine Consultancy is responsible for conducting successful audits for the European and UK pharmaceutical companies. This has been the reason behind favourable regulatory pharmacovigilance inspection outcomes. We perform both self and external audits to ensure that the client receives the best PV system. Our experts can offer a detailed assessment of the current system that you have in place and also offer valuable advice regarding the ways you can improve your system. MHRA has conducted a successful inspection of our Consultancy services on many occasions.

Training

The staff members who will be contacted regarding the adverse drug reaction need proper training on ways of recognising it, handling it, and proceeding forward to deal with it.

Our experts can offer the necessary guidance regarding the drug safety training to ensure they meet all the requirements.

We also offer customised training based on the needs of an individual, such as the following:

Volume 10 and Clinical Trials Directive Training
Pharmacovigilance Auditing
Basic Pharmacovigilance Training for PV professionals
Basic Pharmacovigilance Training for non-PV staff
Intermediate Pharmacovigilance Training for PV professionals

PV Systems and Documentation

We are capable of developing PV systems for you and prepare the necessary documentation for the clients.

Pharmacovigilance System Master Files (PSMFs)
Standard Operating Procedures (SOPs)
Development Safety Update Reports (DSURs)
Risk Management Plans (RMPs)
Periodic Safety Update Reports (PSURs)
Named patient / compassionate use program Annual Safety Reports