Pharmaceutical / Biotechnical: Market Phase


Learn How MasterControl Supports the Cross-Functional Team in Pharmaceutical / Biotechnical Market Phase

The market phase in the pharmaceutical and biotechnology industry, if well coordinated and properly executed, can provide the company with rapid product uptake and dramatically increased revenues. Public relations coordinated through sales and marketing, in collaboration with the regulatory team, is very important as is manufacturing (with manufacturing quality oversight). One day of plant shut down due to a compliance audit can significantly damage revenues and the company's ability to recover. The ability to quickly demonstrate best practice policies and procedures is critical both for maintaining smooth manufacturing operations and for FDA compliance. Effective communication among teams that may not be in the same facility is also critical. MasterControl Document control and management software can help by providing a centralized, web-based document repository that enables all team members, regardless of location, to access (or automatically receive) important documents and reports. MasterControl software for automating batch records, as well as the corrective and Preventative Action (CAPA) process, while integrating it with other quality processes such as change control, SOPs, and employee retraining, enhances efficiency and reduces man hours, while ensuring FDA cGxP compliance.

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Market Phase Software Solutions

  • MasterControl Documents
  • MasterControl Collaboration
  • MasterControl Process Automation Solutions
Controlled Documents Managed in the Market Phase Collaboration Workflows in the Market Phase
  • Adverse events
  • FDA reporting
  • Potential post marketing surveillance
  • GxP audits
  • SOPs
  • Inventory and supplier documents
  • Equipment/calibration documents
  • DMR documents
  • Nonconformances
  • Distribution complaints and CAPAs
  • Change control documents
  • Compliance audit reports
  • Publications for professional journals
  • Research, design, and implementation documents
  • Sale revenue and inventory documents
  • Other submission documents needed to secure foreign regulatory approval
  • Possible material review board (MRB) meeting documents
  • Chemistry and pharmacology study data
  • In vivo study data
  • Biomarkers
  • Formulation studies
  • Statistical analyses
  • Market analyses
  • Potential revenue forecasts
  • Corporate communications and investment presentations
  • Inventory and Distribution:Coordination between the manufacturing team and sales and marketing is necessary for the effective management of company resources.
    • Pharmaceutical and biotechnology products have a specific shelf life, which makes proper inventory and distribution critical for managing expenditures involved in product sales.
    • Many products are sampled in physicians offices. Maintaining proper inventories is important and needs to be managed to ensure that supplies reach sales representatives when needed.
    • Wholesaler orders and demands will also fluctuate, especially during the critical launch period. Sales and Marketing must vigilantly monitor field activities and match demand with supply.
  • Regulatory and medical communications: Discovery and development research and the sales and marketing teams work with external principal investigators (PIs) to publish manuscripts on study results. These publications, along with the educational materials and promotional activities that support them, must be approved by the regulatory and legal departments.
  • Regulatory and manufacturing: Manufacturing (including manufacturing quality) is the primary focus of the market phase. One day of plant shut down due to a compliance audit can significantly damage revenues and the company's ability to recover. The capability to quickly demonstrate best practice policies and procedures is critical to maintaining FDA compliance and smooth manufacturing operations.
  • Regulatory and the company as a whole: Throughout the market curve of a drug's life, regulatory communicates with the FDA on issues regarding adverse events, additional indications, and label changes. The sales and marketing and legal departments, as well as the company's management, are in constant communication with the regulatory team.
  • Product lifecycle and portfolio decisions: Because the initial product market response determines lifecycle and portfolio decisions, the entire cross-functional team must be informed and provide information relevant to their domain in order to facilitate timely, accurate, and effective decision-making about the product and its future.

MasterControl Collaboration Software:

  • Provides a web-based, virtual workspace for collaboration.
  • Facilitates the decision-making process among cross-functional team members on issues related to lifecycle and portfolio management.
  • Facilitates the ability of internal scientists and other members of the cross-functional team to collaborate with one another and with external PIs and medical writers on manuscripts for scientific journals.
  • Creates system transparency, enabling authorized users to see where collaboration documents are in the review process.

Process Automation Software

  • MasterControl Change Control
  • MasterControl Training
  • MasterControl Nonconformance
  • MasterControl CAPA
  • MasterControl Deviations
  • MasterControl Audit
  • MasterControl Customer Complaints

Contact for More Details on Pharmaceutical and Biotechnical Market Phase

To get complete details about pharmaceutical market phase and biotechnical market phase, feel free to contact MasterControl representative today.