Vendors Database

Panacea is a leading provider of pharmacovigilance, regulatory affairs, and quality services. Our flexible and responsive technical teams help our clients in a variety of ways; whether it is a one-off task, a fixed-term project or a continuous relationship.

Our services include:

 Pharmacovigilance

Full and ad hoc services including:

• UK & EU QPPV services
• Local PV services (EU / worldwide)
• Risk Management Plans (RMPs)
• Periodic Safety Update Reports (PSURs)
• Case processing
• Signal detection and management
• Fully validated pharmacovigilance database
• Global literature monitoring

 Regulatory Affairs

• MA applications and lifecycle management
• Product Information preparation and maintenance
• Quality Overall Summaries
• Clinical and Non-clinical Overviews
• XEVMPD maintenance

 Quality

• Quality Management System (QMS) review and gap analysis
• SOP reviews, writing & implementation
• Maintenance and management of Pharmacovigilance Agreements / SDEAs
• Inspection preparations / training
• Creation and maintenance of Pharmacovigilance System Master Files (PSMFs)
• Pharmacovigilance training

More than just Clinical & Post-Marketing Pharmacovigilance (Medicines; Devices; Vaccines; Biologics; Advanced Therapies; Cosmetics and consultancy, as a Global CRO with clients in all 7 continents we offer  Global Auditing (GCP; PV; IT Validation; Due Diligence; Gap-fill analyses); Medical Affairs (Medical Information; Promotional Sign Off; FAQ design; multi-lingual support; competitor analyses); IT Informatics (Safety Database selection; upgrades; safety database support; Automated case Processing RAPTAR); Training (via SaPhar PV; Medical Information; Cosmetovigilance – Remote; Bespoke; On-site); Global Regulatory Strategy and Support for licence submissions for all product types

Professional Indemnity Insurance -20% discount for PIPA members

In the event of a claim or incident occurring, you’ll not only have peace of mind, but a saving on your personalised insurance

Cover can be arranged for individuals and companies based in the UK and overseas

We can also provide Employers/Public Liability/Property/Cyber Insurance

For more information please contact us on 0121 694 6897 or info@piacommercial.com and mention you are a PIPA member

PrimeVigilance, an Ergomed plc company, was set up by former Pharmacovigilance Regulators in 2008. We now have inhouse over 800+ employees. We have grown to become the leading Pharmacovigilance specialist company, delivering global solutions for clinical safety and post-marketing pharmacovigilance and medical information from our operational hubs based in Europe, the USA, and Japan.  Having delivered Pharmacovigilance (PV) and Medical Information (MI) services for over 14 years, our extensive experience enables us to offer a comprehensive, top-quality, cost-effective, and innovative safety solution. Our flexible approach, tailor-made to work with clients, allows us to deliver the services that meet your clinical and post-marketing needs. PrimeVigilance provides pharmacovigilance solutions to over 200 clients who distribute their products worldwide. PrimeVigilance manages a global Pharmacovigilance system with a choice of leading drug safety databases, stretching to more than 100 countries. PrimeVigilance is the leading provider of EU Qualified Persons responsible for Pharmacovigilance (EU-QPPVs), who fulfil specific responsibilities laid down in EU regulation and include the provision of Local Contact Persons for Pharmacovigilance (LCPPV). For more information about PrimeVigilance, visit https://primevigilance.com/

SaPhar is the sister Company of PharSafer and has been offering global safety training for Companies for the last 20 years. The courses cover everything from Introductory; Intermediate and Advanced level Pharmacovigilance set courses through to themed training (e.g. signal detection; RMPs) and also bespoke courses for clients. Over the years we have trained over 6000 people F2F and over 1000 people remotely. Our experienced trainers offer courses in Medical Information; Cosmetovigilance; Materiovigilance (Medical Device vigilance) Auditing and topics such as the PSMF. Our courses are flexible and can be split into ½ day courses to fit with the working day. Whatever your training needs, call us to discuss.