Founded in 2003 by Dr Graeme Ladds, PharSafer® is a specialist Contract Research Organisation (CRO) in Global Clinical and Post Marketing Drug Safety, and Medical Services, with a wealth of experience in Pharmacovigilance, Auditing and Medical Affairs – and the various, numerous and extensive legal safety/medical obligations for licence holders to comply with – as well as Regulatory Strategy for the best methods for obtaining scientific advice concerning licence submissions and approvals.
Together with our sister company which focuses on Training: SaPhar, PharSafer® continuously seeks new and innovative ways to provide added value for our global clients – going above and beyond expectations and optimising processes and procedures involved with clinical and post marketing drug safety and licencing approach.
Our ability to offer first-class services in Pharmacovigilance, Regulatory Affairs, Training, Auditing, Medical Affairs and IT Informatics means that, for many clients, we operate as their Pharmacovigilance and Medical Departments – guiding them through the labyrinth of drug safety and medical legislation, all in the interests of ensuring patient safety and client compliance.
We love what we do. We love finding solutions. Quite simply, we are by far... Your leading partner in Drug Safety.
As specialists in global clinical and post marketing drug safety, we consider Safety to be the centrepiece of our services and the foundation of our business.
From routine pharmacovigilance services, such as the individual case processing of adverse reactions (ICSRs); comprehensive literature searching; signal detection; periodic report writing; risk management/minimisation and medical device safety, all the way through to more bespoke service offerings, such as vaccines; biologics; cosmetics; advanced therapy products; drug-device combinations and many other consultancy services, PharSafer® will advise and guide you on your way to meeting your regulatory compliance obligations.
To help clients effectively navigate the complex regulatory landscape and meet their regulatory compliance obligations, PharSafer® support clients by preparing and submitting the varied regulatory filings world-wide, utilising scientific advice in development programmes for filing strategy; monitoring regulatory changes, and understanding the various mechanisms for obtaining licences for different product types e.g., herbal; traditional; generic; OTC; innovator.
Whether it be performing comprehensive regulatory compliance assessments, developing and maintaining the Global Product Labelling and Core Data Sheets or undertaking activities such as Licence extensions in new territories with new indications and formulations, our team has many years’ expertise to ensure our clients receive a first-class service.
As the sister company to PharSafer®, SaPhar Training® provides pharmaceutical professionals with introductory, intermediate and advanced level practical training, in addition to bespoke training courses that are tailored to the specific needs and requirements of a client, covering a wide range of subject areas within global clinical, GCP, signal detection, post marketing drug safety, medical affairs, cosmetovigilance, audits and inspections.
These training programmes can be conducted face-to-face or online and are designed to help equip professionals with the necessary skills and knowledge to effectively navigate the field of pharmacovigilance at various levels of proficiency ready for them to make practical decisions for the future.
PharSafer® understand the importance of being compliant and not only passing or ‘getting through’ audits and inspections but excelling in them; applying a constant quality improvement philosophy through the work of our White Gloves Audit Group, with over 75 years of senior auditor experience performing GCP and GPV audits against multinational legislation requirements, as well as 21 CFR Part 11/GAMP 5 audits on system validations.
When forming a partnership with a client, we agree to see ourselves as an extension of their brand and Company ethos, protecting their reputation as we would our own, as we understand that any failures in compliance may result in significant consequences to their brand and to their product’s ability to produce revenue; guaranteeing that all standards of work are upheld to the highest possible standard, both within PharSafer® a...
Whilst we place great emphasis on the importance of pre and post marketing drug safety, we also place absolute value on the importance of peace of mind for both our client and our client’s stakeholders – ensuring the products are used properly and information is accurate and up to date to be provided to Healthcare Professionals and patients alike.
To complement our services in clinical and post marketing drug safety, we provide interactive medical services within our Medical Affairs Group that cater to the needs of our client’s stakeholders (for medicines; devices; cosmetics; vaccines; radioisotopes) to ensure their brand is supported to the highest possible ethical standard.
At PharSafer®, we add value to our first-class service by not only going above and beyond expectations for the task at hand, but by always looking ahead and recognising the need for change before your competition through applying cutting edge technology and our internal expertise and ingenuity.
By continuously evaluating the processes and performance of our business, we constantly seek out opportunities to both expand and improve on the quality, breadth and depth of our services through IT development for practical solutions, in addition to raising the bar for standards across the wider industry.
PharSafer® Informatics is your absolute first choice for efficient process management and integration for pharmacovigilance, medical affairs and regulatory activities.
With safety case processing increasing year-on-year, the cost of recruitment and training on the rise, and human error, lack of timely and consistent follow-up and late case submissions all continuing to be reported as regulatory inspection findings, the need for an improved system of capturing and processing adverse reaction reports, for both clinical and post-marketing, has never been greater!
With both HCP/Investigator defined forms and patient friendly reporting aids, R.A.P.T.A.R® integrates with any safety database and is the case processing solution for the rapid, automated, processing and tracking of adverse reactions.
Don't just elevate your safety – transform it with R.A.P.T.A.R® and book your demo today!
| Date & Time (EST) | Title | Presenters |
|---|---|---|
| On Demand Only | Top Considerations for Drug Safety Compliance in 2023 | Graeme Ladds |
CEO & Owner
PharSafer
Ripley, Surrey
Office: 01483212155
graemeladds@pharsafer.com
