High clinical costs with declining drug discovery success rates are causing productivity levels to fall in the global pharmaceuticals industry. The imminent patent expiry of several major blockbuster drugs and the related rise of cheaper generic alternatives is further exacerbating the situation. Despite this, the global pharmaceutical industry offers significant growth opportunity for participants that can build new strategic business models.
Pharmaceutical
Industry Challenges:
- Managing huge Drug Research and Development data effectively.
- Monitoring research & development projects along with Drug R&D Data.
- Collaboration & restricted data sharing with various internal & external stake holders.
- Preparation for regulatory submissions on time to time basis.
- Connecting all elements of drug discovery and development together.
- Cumbersome processes for accessing recipes and analytical information, capturing formulation details efficiently and securely, and sharing and managing workflows and data between teams.
Role of IT Infrastructure:
IT infrastructure plays critical role in growth of the organization and business. Today’s visionary CXO identifies IT infrastructure investment as crucial and important as other physical infrastructure to have scalable, process driven and globally accepted organization. IT Infrastructure is becoming primary need of the industry to work with global customers and winning more business.
Well controlled organizational process and project execution with IT infrastructure is winning factor for today’s industries. It directly affects top line of the organization.
SteepGraph Systems Industry Offerings:
At SteepGraph, we understand your Business Goals, Business Processes and Challenges. We have vast experience serving customers in pharmaceutical industry. It helps us to understand industry’s business processes, functional best practices, compliances & standards, growth hindrances and key challenges of the industry. Apart from industry functional knowledge, SteepGraph has specialized skills in Enterprise Software and IT infrastructure related to PLM (Product Lifecycle Management), Business Process Management, Project Management, Product Data Management, Collaboration, Efficiency Improvement, Supplier Management and Enterprise Resource Management.
With Conglomeration of Industry skills and Software skills, SteepGraph helps its customers to achieve measurable growth and competitive edge with consulting, Lean Enterprise Process Implementation, Enterprise Software Integration, Training and Support.
SteepGraph Systems’ Expertise:
- Project management
- Formulation Development Management
- Quality By Design(QbD)
- Recipe Management
- Analytical Method Development & Validation Management
- Clinical Management
- Stability Study Management
- Dossier Compilation
- Integration with SAP EPR
- Bioequivalence Study
- License Management
- Document Management
- LIMS
- Material & API Management.
- Collaboration with CRO & CMO
- Batch Management
SteepGraph Systems Solutions for Pharmaceutical Industry:
PHARMALEAN solution is designed for Pharmaceutical Research and Development companies to handle all need and challenges in most efficient, effective & accurate way faced by this industry. PHARMALEAN offers a comprehensive set of research data for easy analysis and interpretation of the massive datasets. The flexibility of PHARMALEAN allows you to accommodate current industry needs, as well as adapt to government compliances that are rapidly emerging in the Pharmaceutical Industry. Quality control is an integral part of PHARMALEAN and there is full support for compliance with regulatory authorities such as Food and Drug Association (FDA), Central Drugs Control Organization’s (CDSCO). The analysis based on methods and for methods are part of PHARMALEAN is adhere to regulatory authority controls like US Pharmacopeia (USP), Indian Pharmacopoeia Commission (IPC) or European Pharmacopeia (EU). PHARMALEAN solution provides functionality supports complete formula and recipe management. Functionality provides complete visibility to specific ingredients, intermediates, and formulas which are used in the production of multiple products. Through the integration of formulas and associated processing instructions and notes, process manufacturers can create recipes which are used during batch process production. PHARMALEAN supports Good Manufacturing Practices (GMP) through audit controls of transactions, electronic signatures, and version control with engineering change management of formulas and bills of materials. PHARMALEAN is complete package which enables a centralized trial management database for all investigators with adoption of compliances prescribed by Clinical Trials Registry- India (CTRI). PHARMALEAN is integrated Drug Development Life Cycle Management which traverse through discovery Phase to Manufacturing Phase. Easy to manage New Drug as well as Generic Drug cycle.