Synergy from collective expertise
There’s a reason that strategic consulting is essential to the long-term success of your products. The sooner you engage us as a strategic partner, the sooner we can plan and deliver on your requirements, faster, better, smarter.
Success is about analyzing your long-term goals and knowing whether it’s more advantageous to choose one procedure or route over another. It’s about pinpointing which activities are best conducted with which vendors, and which should be in-house. It’s about having the in-depth knowledge of Regulatory Affairs, Pharmacovigilance, and Quality Management...and using that knowledge to provide strategic guidance that achieves your goals faster, better, smarter.
Life Sciences Consulting Informed with Regulatory Intelligence
The long-term viability of your product can rise or fall on regulatory developments. Staying abreast of changing requirements is critical for a strategy that’s relevant for today...not six months ago. At Arriello, Regulatory Intelligence profoundly impacts our life science consulting services.
We’re constantly gathering new regulatory data thanks to our global network of vendors and our in-house capabilities. We consistently monitor the EMA and HMA’s websites, and our local vendors keep a constant watch on new developments from their respective National Authorities and official sources.
Our life sciences consulting service provides solutions that take account of what’s needed now, what’s on the horizon, and how to keep potential risks to a minimum.
Our 5 step process
Providing life sciences consulting that meets your objectives starts with listening very carefully to your current and future objectives. The correct assessment at this stage is critical to delivering faster, better, smarter results for your organization.
Once we’ve gathered all the relevant information our in-house experts can analyze your situation. Our team’s expertise in Regulatory Affairs and Pharmacovigilance draws upon 25 years of high level experience working across the EU, LATAM, MENA, CIS, APAC regions and South Africa.
After thorough analysis, we’ll work with you to explore and discuss the results and what they mean in relation to your objectives. Again, this is a critical step because getting this right is absolutely crucial to developing our solution.
Having shared and reviewed our analysis with you we’ll propose a solution to meet your requirements, a solution built around our faster, better, smarter ethos.
Once we’ve developed and agreed on the best strategic plan for your needs, we leverage our in-house capabilities, our external experts and our global vendor network to deliver on the execution.
Health Authority Briefing Packs
Health Authority briefing documents are an essential tool to support you with your interactions with health authorities such as pre-submission meetings, requests for scientific advice and protocol assistance. These interactions can shape the clinical development of a product and as such are clearly of great importance to companies. A well-written and presented briefing document may be crucial, or at the very least, can smooth the path to the desired outcome.
With our considerable regulatory background, we can prepare a briefing document that is readable, clear and has the maximum impact. It will give the best picture of what your product is, its key benefits and why it is a necessary addition to improves people’s lives.
Scientific advice and Health Agency meetings
A Scientific Advice meeting is your chance to move your strategic position forward. Our experts have a wealth of experience preparing and attending such meetings on behalf of our clients.
We can devise and deliver a trustworthy feasibility study for Over-The-Counter Switching to assist you in planning for your target markets. We conduct a rigorous review of the likelihood of a possible switch of individual molecules, both from a clinical and a regulatory perspective, in various therapeutic areas.
We are also able to support you with other OTC support activities, such as Health Agency meetings and OTC Marketing Authorisation Applications (MAA).
Audit/Inspection Readiness - AIR
If you’ll soon undergo an audit, you don’t have to face it alone. At Arriello, our experienced team has a deep understanding of the auditing process.
We are audited numerous times each year as part of the auditing process of our clients as they themselves either prepare to be audited or, as part of a health agency inspection, where we are part of the system they maintain. True to our faster, better, smarter ethos, we are fully ISO: 9001 Certified for Quality Management and we are able to offer this expertise as a service.
With our team, you can...
- Have Arriello audit your organization for best practices through a detailed gap analysis and report.
- Prepare for a Good Pharmacovigilance Practice (GVP) Audit.
- Ready your team for a Health Inspection Audit.
- Learn how to audit internal teams and vendors.
More about support services for audits and inspections.
Looking for a strategic consulting partner?
We combine years of experience in Regulatory Affairs, Pharmacovigilance and more to anticipate problems, identify opportunities, and deliver a faster, better, smarter strategic solution.