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We were internet marketers that needed a break. So we started a tapas restaurant in Spain. Some said we were crazy, some said we were brave. We say we are a little bit of both. Read our story, the lessons we learned and our tips…..

It h

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

as been almost three years since we moved to Spain and finding our way around has been fun and sometimes a struggle. When you move abroad you realize that you are giving up your career, your house, the lease car and all. But in return,

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

there is a romantic future lying ahead of you; a future without stress, traffic jams, thousands of emails a day, dark clouds, rain. An exiting future with new possibilities, new people and new habits.

Our romantic and exiting idea of th

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

e future was setting up a tapas restaurant in a pretty little village on the Costa Blanca. We would only open for a few hours per day, run it together, and cook all kinds of delicious tapas for our guests.

We were able to rent a locatio

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

close to a very busy weekly market. Definitely a hotspot. As the unit was completely empty when we rented it, we were able to build it up from scratch. Setting up something new is almost everybody’s dream. And yes, it is a lot of fun. H

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

owever, with only little experience in the catering industry (but not completely brainless), little knowledge of the Spanish language, no knowledge of the Spanish culture or business attitude whatsoever, we were bound to get in a lot of

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

trouble.

But somehow we didn’t… Although it took endless discussions, brainstorm sessions, continuous questioning and numerous drives along the Costa to find the right suppliers and equipment.

Some examples:

Buying kitchen stuff. If y

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

ou want to buy kitchen stuff in Holland, you go to a wholesaler. There you will find all equipment neatly arranged with prices and product details. In Spain only few items are on display and they show no prices at all. We first had to go

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

home to look up all the words in the Spanish dictionary (so we could at least ask what we wanted to have). Furthermore, they gave all prices in Pesetas – on purpose I’m sure - although they kept smiling.

Building the bar was something

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

else as well, because we wanted a non-Spanish bar set-up. That made the beer people, the wine people, and all other suppliers freak and run out immediately with the words ‘ai hombre, problema!’ – probably catching a beer in the bar next

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

door – and not show their face for a couple of days.

In order to get ice-cream, we had to stand in the middle of the street to stop the sales rep and ask him to come in. He delivered once, came for a refill and then never showed up agai

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

n. Hence, we had to change brands in the middle of summer..

It took us 2 years to finalize the paperwork for the license. It took numerous visits from the ‘ajuntamento’ and the health inspection before they finally approved it. Each ti

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

e they came, they brought a new list with rules and regulations, ensuring us this was the final version.

However, once set up, the restaurant worked really well. Some people said we were crazy starting a tapas restaurant in Spain, but w

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

e managed to serve both foreigners and Spaniards, which made us very proud.

After 2 years we sold the restaurant to start a new adventure. Because we had such a hard time finding the right stuff at a reasonable price for the restaurant,

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

but also for stuff at home, we set up www.CostaMarket.com, a marketplace for people living on the Costa or with plans moving there. We have just started, which is both exiting and scary, but again I’m sure we will manage somehow…

Our T

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

ips:

Running a bar/restaurant is probably one of the most effective ways of learning Spanish, Spanish culture, the local way of doing things (probably different for every part of Spain) their rules and regulations, their business cultur

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

etc. Plus, you hear A LOT

ASK! In Holland everything is arranged for. Information is brought to you whether you want it or not. The Dutch are great at logistics. In Spain you ask for it – always, in every situation, anytime – always a

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

sk. Even if it seems the most silly question in the world, there’s a good chance they will answer with ‘Hombre, claro que si!’ Of course we have/do it!

Ask AGAIN. Chase, call, visit. If they don’t hear from you, it is obviously not impo

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

rtant to you.

TWICE. Never ever think you get anything done in ONE go. There is no way. Plan two to three visits/attempts for anything you need to arrange. Knowing this in advance will save you a lot of stress.

SMILE. But that is proba

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

bly a universal tip.

RELAX. You want to move to Spain (or just did) because you wanted more time etc. Go with the flow!!

CostaMarket.com – if you need any second hand stuff or if you want to sell something – do it on www.CostaMarket.co

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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I sense that you are still feeling a little separated from your customers. You are shifting your focus from your own income, to giving to customers, to help their lives grow and blossom. I think you are still missing the point.

Link exchanges aren't dead, not if you know how to properly user them. Learn how to make a link exchange look natural, and how to make sure the search engines reward you for using a link exchange service rather than receiving a penalty.

Ebooks are an easy way to make money and fast too! Ebooks can be written on millions of different topics. Simply choose one that interest you and go! As with any writings, you brainstorm. Determine what your topic is, and branch on from there. Each topic is very broad so narrow it down to one or two main points that you will cover, as this will leave you with more books to write at a later date! Begin gathering the information you need. Perform all the resource to provide you with enough information to provide the reader with adequate knowledge upon completion of you Ebook. Then start writing your book. This may take some time depending on how long your book is the topic you are covering and the materials you found. After the book is written, use many sessions of proofreading, even hire someone to look ...

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Answers - Moving to Spain: Tips and Lessons Learned

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