About Us
Safeguarding your Pharmaceutical Success
With over 40 years of industry experience, we specialise in pharmacovigilance, regulatory affairs, and medical support. Our team delivers trusted expertise to ensure compliance, mitigate risks, and support your pharmaceutical success.
Expert Local Affiliate Support
Provision of compliant and streamlined local affiliate support, ensuring that your compliance needs across regulatory, pharmacovigilance, quality and labelling are met
Streamlined Pharmacovigilance and Regulatory Affairs
Ensure patient safety with tailored solutions, including adverse event reporting and risk management, meeting global standards.
Simplify regulatory submissions with expert support for SmPC, PIL updates, risk mitigation, and consultations.
Tailored Medical Support Solutions
Enhance efficiency with services such as medical information setup, medical writing, BE study design, and expert-crafted standard response materials.
Also support with repurposing and reclassification activities.
Effective Organisational Setup
Optimise your operations with tailored organisational design, strategic planning, and assistance with recruitment of key personnel to drive your continued success.
Our Results
We are well established in providing services to ensure compliance, with a deep knowledge in PV and regulation.
20
+
Audits
We have delivered over twenty audits of pharmacovigilance service providers, MAH, and bioequivalence studies in line with Good Vigilance Practice/Good Clinical Practice requirements.
5
+
Authority Inspections
We have successfully managed and led multiple inspections by Competent Authorities, ensuring full compliance and readiness.
40
Years of Experience
With years of industry expertise, we deliver reliable, high-quality solutions in pharmacovigilance, ensuring client needs are met.
Over 40 years of industry experience.
Experts in Compliance.
"An extensive experience in Regulatory and PV practice, producing excellent and valued outcomes. A fantastic capability to understand what issues may exist and bring innovative solutions to resolve complex problems with a balanced approach to understand the commercial imperative and matching this accordingly to absolute requirements of regulations within the pharmaceutical market. An asset to any organisation that engages their services"
- Derek B, Managing Director
"With your combined experience and knowledge and your practical approach to getting things done your venture will thrive"
- Mary O, Director of Regulatory Affairs, Ireland
“Consistently exceeding expectations in their many roles, their dedication, attention to detail and commitment to compliance were invaluable.”
- Peter K, Head of Generics Business Unit
"Jackie and Lisa understand the global nature of pharmaceuticals, they are easy and fun to work with. I would highly recommend their services."
- Marianne K, Senior Director Comms, USA
"Lisa’s wealth of experience and dedication to improving compliance and patient safety would be a tremendous benefit to any project and her ability to collaborate across functions is invaluable"
- Nat K, Director
I'm sure your new venture will be a valuable addition to the industry
- Phil K, Commercial Manager, UK
Insights and Updates
News
Keep up to date on the latest industry trends and regulatory news. Explore insights and expert perspectives to stay ahead .
