Analytical laboratory services are gaining importance these days as analytical testing has become an undetachable part of the drug discovery and development process. Both the qualitative and quantitative results generated from the analytical testing provides sufficient information essential for controlling both the quality and safety of the pharmaceutical drug candidate and the finished product.
With the increasing complexity of the pharmaceutical drug substances and drug development, the processes related to the formulation and manufacturing of pharmaceutical entities are increasing rapidly. Outsourcing of wide varieties of essential analytical testing processes where there is no need for extensive training sessions, expertise, and analytical equipment has, therefore, become a pre-requisite.
The importance of quality, costing, and turnaround times –
Manufacturer’s wandering in search of analytical testing service providers peeps out for qualities such as technical performance, the data quality, and the efficiency of the accomplished tasks. Nevertheless, strict adherence to drug regulatory compliance is also a matter of grave concern. Cost of the analytical laboratory services does remain a key factor for additional commoditized services. Yet, for most of the pharmaceutical giants, the cost may not always be the deciding factor. Instead, they prioritize cost versus value equation as the prime key objective for selecting the best analytical laboratory services. Most of the pharmaceutical clients are ever-ready to pay whatever it costs for the service promising measurable value.
For the success of the pharmaceutical industry, the quality of the analytical testing services, turnaround times, and the testing efficiency are of prime importance. The results drawn from this analytical testing procedure helps in arriving at various conducive decisions throughout the entire drug discovery and development process. Consequently, the analytical laboratory service provider can produce an irreversible impact on the drug development process at all stages – a selection of the formulation, manufacturing process, decision making, and release of the clinical trial data.
On the other hand, the concept stands different for those pharmaceutical companies who are still in their nascent stage. These industries focus on the analytical laboratory service provider as a differentiating factor for their selection. Such nascent pharmaceutical firms may require the assistance of these outsourcing analytical laboratory services concerning filing new drug applications to NDA filings to addressing the regulatory compliance questions raised by several concerned drug regulating agencies. Thus, the analytical testing service should be proficient enough concerning the understanding of the drug discovery and development process and complying with the regulatory requirements. Additionally, they should display both willingness and ability to serve their pharmaceutical business partner both with the required customized support and real added value.
Most of the analytical laboratory service provider focuses on offering innovative measures such as creative risk sharing, financial incentive solutions, and dedicated resources. A negative impact of the analytical testing hampers the program quality, deadlines, and the final cost involved in the entire process of drug discovery and development.
The demand and requirement for the emerging analytical testing laboratories are increasing day by day to supplement the pharmaceutical giants with their analytical requirements. This helps the pharmaceutical companies for maximizing the utilization of internal resources both for highly complex and allied activities.