Working with pharmaceutical companies over the years, we’ve noticed how important it is to get things right first time and done as quickly as possible, whilst remaining licence compliant and without compromising patient safety.
Why was MODUS born?
For Parallel Importers, licensing problems are one of the major causes of delay in processing stock, the most common being changes in manufacturing sites and leaflet updates. Variations to licences can often take many weeks if not months to be submitted and approved.
There are usually a good number of licences in any portfolio that are under some form of variation and it can be a challenge to work on and submit those variations. Getting them approved and ‘live’ in your system can also be a time-consuming prospect.
Having worked within the Regulatory departments of several parallel importers over the years, we’ve seen the problems that can arise with keeping licence portfolios valid. We understand how stock on-hold can impact and affect all aspects of your business and the departments and staff within your company.
It's vital to keep your licence portfolio up to date and this includes adding to it with new licences and products. If you’re the first with a new product, you can have exclusive access to the market. But you need to get that licence submitted quickly – which can be tricky when you have lots of variations to work on to keep current stocks moving through your unit.
For Wholesale Dealer Authorisation (WDA) holders, there are more aspects to be concerned with. Good Pharmaceutical Practice (GxP) must always be observed. Whilst a WDA holder cannot improve the product quality, it has many opportunities to cause the product to suffer damage, which is unacceptable.
The most common deficiencies noted in past inspections were to do with Temperature Mapping and Control, Documentation and Procedures, Training, Quality Management Systems and duties of the RP, and Transportation.
Quality Management Systems play a huge and necessary role for any holder of a WDA. It involves CAPA, Training, Change Control, Documentation, Validation, Risk Assessments, Audits and Self-Inspections to name but a few.
A good and competent Responsible Person (RP) is needed to ensure systems are put in place and are followed. They must work closely with all members of the company from the Managing Director to the Warehouse staff to ensure GxP. All members of the company play a pivotal role.
MODUS was set up with all of this in mind.
So what can MODUS do for you?
Not everyone likes to admit when they need help. It’s difficult to put your hand up and say “I can’t cope”. We get it. That’s why MODUS was created. We’re here to help.
We’re fully trained RPs and can help you to keep your WDA/MIA licences compliant.
We have many years of knowledge and experience in the PI Regulatory field and can assist in keeping your product licences current. Getting it right first time can be crucial.
We can review your systems and processes to help you streamline and improve the way you work. But don’t worry if you’re already working in the best way possible – we won’t interfere and change the way you work if it’s not needed.
How does MODUS work?
We believe in working with you to help you achieve your goals and objectives. We’ll integrate into your teams and will keep disruption (if any) to a minimum.
No matter how big or small the task is, we will work with you to get it done quickly and efficiently.
We will ensure licence compliance at all times and would never compromise patient safety.
We want you to feel confident when working with us, so that you can trust and depend on us to help you deliver on your commitments.
We’d love to come and meet you to talk about what you want and to see how we can assist you.
If there’s anything else we can help you with, please contact us.
Call us on 07894 712912 or 07403 756965
Email us on email@example.com
Or use our contact form and we’ll give you a call back.
We look forward to hearing from you soon.