Present Challenges:

Pharmaceutical companies are typically looking at improvements in the development, managerial and operational processes to reduce the development and approval time which now consumes almost 12 years. Newer technologies in the areas of combinatorial chemistry, genomic, bio-informatics and screening processes that identify promising drug candidates using computerized screening techniques are being pursued.

The operational and managerial processes are also being given serious consideration for ensuring efficient use of resources, enabling improvements in productivity and streamlining the research processes, hence reducing inefficiency, eliminating repetitions, conserving critical & expensive resources, protecting intellectual property and ensuring compliance with International IP statutes and Industry Regulatory requirements.

Pharmaceutical companies are working on several strategies to reduce the time and cost of drug development. The last couple of years have seen major shifts in strategies regarding drug development. These new strategies have created new opportunities in the following areas:

• New Drug Discovery (NDD) – a sacred epitome and closely guarded secret– is now being outsourced, hence getting a larger number of scientists and companies working on NDD. The costs are shared, the risks are shared and when the molecule becomes successful, the rewards too are shared.
• Clinical Trials – A monopoly of the advanced economic markets – has now been breached with the realization that countries like India & China have diversity in their pool of target patients. With their improved abilities to invest in State-of-the-Art facilities, improving control over the clinical trial protocols, faster analysis of data and compliance with Current Good Clinical Practices (cGCP) and Current Good Laboratory Practices (cGLP), Clinical trials are more economical when carried out in these geographies.
• Process development – another bastion of confidentiality and intellectual property – has been forsaken for harnessing the high level chemistry and biology skills available in markets like India to come out with cheaper manufacturing processes.

However, Enterprises have to equip themselves to the handle new challenges in area of New Drug Development (NDD), custom synthesis, analytical testing, in vitro, in vivo, Novel Drug Delivery Systems (NDDS) and clinical trials. The processes have to be followed to establish compliances in the areas of

• Budgetary control over costs & expenditure
• Utilization of critical and expensive R&D resources
• Authenticity of processes followed and
• Compliance with cGLP & cGCP

How Does SpectraSoft Add Value:

SpectraSoft offers solutions that help companies improve their drug development & process development processes and ensure compliance with the operational, managerial and regulatory processes hence helping customers reduce drug development time and keep control over costs and increasing utilization of the meager but expensive R&D resources in a better way.