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One of South Africa's best kept secrets, this group of reefs lies between two and four kilometers offshore and at a depth of twenty

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

to forty meters it is for advanced divers. Only 10 minutes drive south of Umkomaas/Aliwal Shoal.

Landers Reef:

Average Depth 21 -

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

Examples of combination products may in

2 Meters : Big pinnacle, large boulders, crevices and huge gullies with small sand patches in between the reefs, caves and overhangs

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

Finger Reef :

Average depth 22 - 35meters: Simply the best, untouched, unspoilt reef around!

Butchers Reef:

Average Depth 18 -2

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

Meters : Boulders, rocks with big crevices and gullies are characteristic of this reef north of Landers. The reef has a wall like f

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

Combination pro

rmation that is approximately 6 meters high. Tropical fish like Trumpetfish, Geometric Moray Eel, Natal sea catfish, speckled shrimp

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

fish, Batfish and False stonefish are just some of the species found here. There is a resident Loggerhead turtle that sleeps in one

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

f the many caves and overhangs. This reef is also known as the Juvenile Nursery. Many species of hard and soft coral.

Cowry Reef:

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

Average Depth 19 - 25 Meters : Big boulders scattered around with sand patches in between and ledges with overhangs and small holes

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

n the reef where Triggerfish hide. There are quite a number of different species of Cowry shells on this reef sitting next to or on

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

he big sea sponges. Coral life consists of soft coral like Dead-man's finger, various colors of Polyp coral swinging in the surge, B

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

Following aspects would a

lack coral trees as well as Green Fern coral with clouds of Goldies swimming around it. Also be on the look out for Nudibranchs; var

dd to the challenges in developing combination products:

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

ous colors and sizes. Hard coral consists of Smooth horned coral and Leather coral.

Outside Landers:

Average Depth 20 - 28 Meters:

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

A wall of reef that run from North to South. On the ledge you can find Pinnacles that form an enclosure for marine life. The boulde

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

s create nice swim through's and gullies. Most of the common tropical fish species seen here although this is one of the deeper dive

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 there tend to be thermo clines here and there. Batfish, Fusiliers, Ragged Tooth Sharks, Nudibranchs and Rock Lobsters are a com

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

Professional from academic institutions, pharmaceutical industries, health care indust

mon sight amongst the many coral species.

Umzamai wall:

Average Depth 23 - 39 Meters: Huge boulders, with big crevices, scattered

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

ocks and gullies to swim through. On the inshore side there is a wall almost 20 meters high with ledges and a cave on the northern s

.

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

ide. Large black coral trees, Polyp coral, White and Pink Thistle coral, Green Fern coral and lots more to be seen on this untouched

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

Companies that provide selfless information through particip

reef. The fish in this area are inquisitive and not used to divers. Big Moorish Idols, Snappers, Triggerfish, Model Tobies, & Boxy's

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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