London, UK: +44 (0)20 3983 7341 | Cambridge, Massachusetts: 617-674-2650 | San Mateo, California: 650-378-1270
We help pharmaceutical and biotechnology companies ensure compliance with evolving global and European regulations in various areas of drug safety. Our solutions in Pharmacovigilance Systems, QPPV services and Drug Safety spread from ad hoc consultancy on scientific or operational aspects to packaged solutions, crafted to your specific circumstance.
We will help you ensure robust safety surveillance in your clinical trials, which includes:
We will help you ensure compliance with European legislation that puts some requirements to companies wishing to market pharmaceutical products in the EU:
The main activities of Drug Safety Science:
Leading safety database
Regulatory expectations regarding compliance with expedited safety reporting requirements are very high. This is why we use one of the most reliable global safety databases on the market.
High quality standards
We ensure that all relevant data reported is accurately reflected in the database, and reviewed by physicians to maximise the value of safety reports. When necessary, we raise queries to resolve inconsistencies or collect important details.
Tight timelines
We work to short timelines to meet regulatory expectations and to minimize the number of follow-up safety reports expedited to clinical sites, regulators and ethics committees.
When you are facing an in-licencing, co-development, co-marketing or another decision that requires assessment of an external compound, we will be happy to assess review presented data under strict confidentiality applying a factual, independent and impartial approach associated risks, their likelihood, impact and suggest mitigation
Copyright
©2020 Olexacon Limited. All rights reserved.
Registered office: Olexacon Limited, One Kingdom Street,
London, United Kingdom, W2 6BD
Phone: +44 (0)20 3983 7341; email:
info@olexacon.com
Registered in England
and Wales, company number: 9110477. VAT Registration Number: 193
8092 76