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    Country on the south-western Europe. Located on the west part of the Iberian Peninsula, Portugal occupies an area of 92,152 km2. It is bordered by
    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
    Spain on the east and north and by the Atlantic Ocean on the west and south.The Portuguese territory is divided in three parts: the mainland, the a
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    utonomous region of Madeira and Azores which have their own administration.

    The mainland is divided into 18 administrative district : Viana do Cas
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    telo, Vila Real, Bragan?a, Braga, Porto, Aveiro, Viseu, Guarda, Coimbra, Castelo Branco, Leiria, Santar?m, Portalegre, Lisbon, Set?bal, ?vora, Beja
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    and Faro; the districts are divided into municipalities (311), which are subdivided into civil parishes.

    The autonomous region of Azores is an a
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    rchipelago of 9 islands, divided in three groups: the western, the central and the eastern. The islands of Flores and Corvo are part of the western
    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
    group, the islands of S. Jorge, Terceira, Faial and Pico are part of the central group and the islands of S. Miguel and Santa Maria are part of ea
    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
    stern group. The autonomous region of Madeira is an archipelago formed by the island of Madeira and Porto Santo.

    The capital of Portugal is Lisbon
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    . Other cities of more importance are Porto, Coimbra, Set?bal, Aveiro, Braga and Faro. The Portuguese terrain has several different forms. On the n
    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
    orth of the Tejo river, it is very rough, with mountains, except the coast plain, and with an average height above 400 meters. These mountains are
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    crossed by valleys and rivers.

    On the south part of the Tejo river the terrain is formed by rolling plains, with low altitude, where the plains pr
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    evail. The highest mountains are located on the north of the Tejo river, and the most importants are Serra da Estrela (1991 m), Serra do Ger?s (150
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    8 m), Serra do Mar?o (1416 m), Serra do Montemuro (1381 m) and Serra do Caramulo (1075 m). On the south of the Tejo river, the most important mount
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    ains are Serra de S?o Mamede (1025 m), Serra do Monchique (902 m) and Serra do Caldeir?o (577 m).

    The rest of the Portuguese terrain is the coastl
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    ine, which can be divided in three big set of plains: the Beira Litoral Plain formed by the alluvial plains of Vouga and Mondego, the Algarve Plain
    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
    and the alluvial Plain of Tejo and Sado. The archipelagos of Azores and Madeira have theirs origins on volcanic activities and theirs terrains are
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    very rough.

    The coastline of Azores has a lot of cliffs and inside the islands the terrain is very mountainous. The highest mountain in Portugal
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    is located inside the Pico island and it has 2351 meters. One characteristic of Madeira is that it has high mountains on the central part of the is
    .

    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
    land.

    The most important rivers are, from north to south of the mainland, the Minho, the Douro, the Tejo and the Guadiana all they rising in Spain
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    and flowing to the Atlantic Ocean. Among the rivers whose course is Portuguese only, we have the C?vado, the Vouga, the Mondego, the Sado and Mira


    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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