Pharma and medical devices companies are having a tough time in meeting the testing guidelines due to the development of combo products and outsourcing has the potential to come to their rescue in this regard. Combo products are selling like hot cakes and with the market expected to shoot up to $9.5 billion by 2009 pharma companies are fighting to introduce new products in this segment.
Most of the companies are not equipped to handle the experience and skills required for testing and validating these products and as a result of this most of the companies may find it difficult to get past the guidelines of FDA.
As per Steven Richter, Ph.D., President, Microtest:
As we anticipate the issuance of new FDA guidelines specific to the research, development, production, and validation of combo products, the selection of an outsourcing laboratory testing partner is nothing less than a critical element for any manufacturer’s successful development and production process of a new combo product.
The best option for these companies at this stage would be to undertake the services of outsourcing companies with regards to testing and validation requirements for combo products if they would want to get past FDA and introduce their products in the market.
Via drugnewswire
