Why Regulatory Affairs?
We at MODUS started our pharmaceutical careers in the Regulatory Department of parallel import companies. It’s a very rewarding role, seeing a product arrive that we helped design at licence application stage, go all the way through the repackaging unit to QP release for patient use. Knowing that the label and leaflet that we carefully created and arranged so that the patient can find the right information quickly and easily is very satisfying. All departments link in with each other at a PI company, but in our opinion, Regulatory is at the heart.
If you don’t have a valid product licence, you can’t buy any stock. You have nothing to goods-in, QC check, or produce, and no carefully repackaged products to QP release and dispatch to customers.
That’s why it’s so important to keep your licence portfolio valid and up to date. The moment a licence goes on hold for whatever reason, you can’t pack any stock against it and therefore can’t sell anything. That stock is stuck in Quarantine until the licence is varied and approved for use again.
There will never be a licence portfolio that is completely up to date and with no pending variations. Products are constantly changing whether it’s for a leaflet update or the manufacturing site has changed or the EU licence holder has been amended. The list goes on.
Not only are changes needed, but renewals and annual updates are required on a regular basis to ensure that a licence remains valid. In addition to all this, and in order to stay competitive, new licences will need to be found and applied for.
The pressure on a Regulatory department is huge. And this is something that we are well aware of.
That’s why MODUS was created. We wanted to be able to help relieve that pressure.
So why choose MODUS?
We know how vital it is for variations to be submitted in a timely manner so that stock isn’t held in quarantine for too long, or to get that new application in as soon as possible so that you’re first to market.
We’re conscious of the impact Regulatory has on the other departments within your company. We know that communication is key to keeping everyone informed of the status of licences, so that critical decisions can made.
MODUS can support you and your company - whether you need short-term fixes helping to complete some new applications or variations, or long-term solutions managing your licence portfolios and training your current staff. We are trained in MHRA licences, EMA notifications and Medical Devices.
We are completely up to date with all of the latest guidelines and regulations so you can be confident that your licences will be looked after properly.
Please call or email to see how we can help you.