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What is a style guide?
The style guide houses all of the relevant standards, requirements, and recommendations surrounding your brand. Covering from the tone of voice to the visual prese

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

ntation all implementation aspects, specifications, attributes and elements you can think of.

It is a complex, detailed document that attempts to meet the needs of a range of users. It has

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

Examples of combination products may in

different main chapters such as the stationery, the corporate web site, the advertisement material ( brochures, flyers, billboards, story boards etc.).

The style guide is a living document

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

and needs to be updated when changes such as re-branding, adding new sections to the corporate web site, using media channels that have never been used before, are taking place. It is a complete gui

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

e to understand your brand and the implementation and how to communicate it.

Why does a brand need a style guide?
The brand identity and brand essence is documented. A strong b

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

Combination pro

rand has a definite personality, and it is on this personality that customers base their opinions and eventual relationship. In order for your brand to build a strong online and offline brand, the pe

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

sonality traits and attributes on which the brand is built must be documented so that developers, graphic artists marketing and communications understands and comprehends why they have to comply to t

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

hese standards and why they have to use for example these color codes for the logo only.

Specifically the usage of the logo, the placement, size and the allowed background colors are docu

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

ented down to the smallest details. These brand attributes reflect your brand's goal and its personality and have to be effectively communicated to your customers and this is why a style guide helps

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

you to guard your brand's consistency.

The style guide makes it possible that your brand is speaking with one voice even if three different departments located in three different location

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

are presenting your brand to your customers. In case there is one day a question which cannot be answered by the style guide, we have to add a new section which is defining how we have to handle thi

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

Following aspects would a

s new situation. This is also the reason why we refer to the style guide as a living document.

How does a style guide help my brand?
Document the desired brand attributes for 2

dd to the challenges in developing combination products:

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

05/2006 and beyond and you will see it is easier for your staff to follow up these guidelines and requirements, because they can simply look them up at your Intranet or they can consult a printed ver

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

sion. They can see and will understand the reason behind demands.

When a brand is for example re-branded to effectively make the “invent” theme tangible for your customers, you must commu

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

icate new brand attributes in everything you do. Therefore the new brand attributes have to be defined and documented in the style guide.

When there is no web site yet and a company is hi

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

red to develop a corporate web site they should consult the style guide first to present the brand consistent and loyal to its brand image on the internet. The style guide has to be updated when the

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

Professional from academic institutions, pharmaceutical industries, health care indust

edia portfolio of the brand is extended (as in this scenario of the the corporate internet web site ). This means the chapter "Internet" will be created and added to the corporate style guide, with a

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

ll its details such as design rationale, guidelines, specifications of all elements and the implementation rules for the Web.

The copy writers and technical writers will create a comprehe

.

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

sible handbook from the collected data of the internet project and add this as a chapter to the style guide. The persons responsible to maintain the site will have clear answers and rules to the ques

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

Companies that provide selfless information through particip

tions when adding sections. This helps your employees to make the right decisions in communicating the brand and present it, live it, communicate it, visualize it to the public in a consistent manner

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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