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REACH Sameness Testing & Read-Across Services
YOU ARE HERE Home Analytical Services REACH Sameness Testing & Read-Across Services ANALYTICAL SERVICES REACH Sameness Testing & Read-Across Services Method Development Method Validation Method Verification Stability Studies Routine Product Release Multi-Disciplinary Projects Problem Solving REACH Sameness Testing & Read-Across Services Concept Life Sciences can assist you with a tailormade program to support your dossier [...]

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Email: answers@agenda1.co.uk

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How We Work

Agenda1 primarily work with companies in the pharmaceutical, healthcare and medical device industries.

How do we work with our clients?

Our way of working with our clients has evolved to ensure a strong focus on their requirements underpinned by our ISO9001:2008 accreditation. As we concentrated in this way a number of common themes and expectations became clear:

Often we work with clients who understand exactly what they need to know, but not how it is to be measured.

Outsourcing analytical services brings the risk that the analysis you get, is not the analysis you need, so we work hard to ensure our proposals clearly lay out what the plan is, and where it fits with your goals. Our proposals are structured to allow frequent break points for project review with our clients. All projects are managed collaboratively with our clients with regular communication by email and teleconference. Unlike many large CRO organisations we encourage direct communication between the client and the analysts carrying out the work.

Often we work with clients who understand exactly what they need to know, but not how it can be measured. This is where our collaborative approach, supported by a very wide range of equipment on site, helps identify the best solution. Our goal is to deliver the data needed to move a project forward (or to say “kill it”) within the deadlines you have.

Sometimes our clients know they have a problem – perhaps a process isn’t delivering what it should, but they don’t know exactly what is at the heart of the problem. We relish these challenges, share our clients concern over the uncertainties created and gain a real satisfaction from finding the evidence needed to identify the cause.

Occasionally our clients are just not used to sourcing analytical services, or the issue they have is new and unusual, we value working on those types of projects, partly because they add to our skill base, but also because they are typically just plain interesting!

With the fast pace of many industries involved in new product development, or product changes, or simply the challenge of JIT manufacture, we know that many of our clients are on a tight time- line, consequently we have developed our business model to aim to deliver to your timetable, and to be honest if that time-table cannot be achieved.

Once the work is commissioned our analytical science team are available to work directly with the project owners, to help ensure that all information about the project is available. Through this approach we aim to make it easier for client project managers to keep all their stakeholders up to date on the project.

Examples

The majority of our clients are from the Pharmaceutical industry, and consequently do not wish to have their programmes publically commented on, however the following three abbreviated “case studies” are representative of our client / programme-specific centred approach, and give a useful sense of how we work.

1. A “virtual” drug development company focussed on a particular niche where life cycle variations of products can be very profitable.  Projects range from method development, stability studies, raw material testing and formulation work. Often the programmes require unusual methods or atypical activities. We have weekly telephone conferences on the same day/time each week to both monitor existing work and plan future work.

2. A multinational pharmaceutical company need to review API testing monographs over a 3 year cycle. We have been cleared to have remote secured access to their document control systems. We review the monographs against an agreed template, identify method changes (if any) and re-write the monographs. We then update the client document control systems, the client local QA team need only to approve the work.

3. A client launched a product requiring a novel micronization technique for which there were no product specific methods available. We formed a virtual team involving the client, the client’s Pharma partner, and a CMO. We developed and validated methods in parallel with the product development, liaising very closely with the QA teams of all three parties to validate multiple procedures and test products to a very tight timeline.