Pharmaceutical companies grapple with high operational costs and lengthy tasks that slow progress and inflate expenses. From drawn-out research and development (R&D) cycles to complex regulatory frameworks, these challenges create inefficiencies across the industry. 

However, Mareana’s Connect™ CMC and Connect™ CPV are transforming how pharma firms manage operations, offering solutions that streamline processes, cut costs, and free up time for higher-value tasks, ultimately providing a more straightforward path forward amid these hurdles.

Operational Costs and Time-Consuming Tasks Hindering Pharma

Numerous operational costs and time-consuming tasks hinder progress and inflate expenses in pharma companies, making it difficult to optimize processes effectively.

 In 2023, the pharmaceutical asset management market was valued at $100 billion and is projected to reach $150 billion by 2030, with an estimated CAGR of 5.96%. Despite advancements, persistent gaps in asset management and process optimization continue to pose challenges to growth and efficiency. These issues must be addressed urgently for companies to remain competitive and manage costs effectively.

 Below are some of the key operational challenges in the pharmaceutical industry that drive up costs and consume valuable time.

Research and Development (R&D) Costs

The R&D process in pharma is a significant financial investment, often requiring years of testing and documentation before a product can reach the market. Extensive clinical trials, paperwork, and compliance checks not only add to the time but also to the financial burden. Delays at any stage of this process can lead to escalating costs, making it challenging for companies to maintain a competitive edge.

Manual Data Entry and Compliance Management

Despite technological advancements, many pharmaceutical companies rely on manual data entry to track assets and manage compliance. Manual processes cause errors and waste valuable time teams could be spending on more strategic tasks. Compliance management, in particular, requires constant monitoring and documentation, which, if done manually, further compounds operational inefficiencies.

Regulatory Complexity

Pharmaceutical companies operate under highly regulated environments, including FDA, EMA, and ISO standards. Ensuring compliance across the entire lifecycle of drug development is time-consuming and costly. Managing audit trails, preparing for regulatory submissions, and adhering to strict guidelines can slow production and delay time-to-market.

Tracking Asset Lifecycle and Expiration Dates

Effective asset management is essential in pharma, but it can be challenging when done manually. Tracking the lifecycle of equipment, chemical expiration dates, and wear and tear are tasks that consume time and resources. Failing to manage these aspects properly leads to inefficiencies, increased downtime, and potential product recalls.

Leveraging AI for Optimal Process and Time Management

AI-powered platforms are transforming how pharma companies manage time-consuming tasks and high operational costs. Here’s how:

Centralized Data Management

AI-driven centralized data management consolidates all information into a single source of truth, eliminating manual data entry across multiple systems. By automating data collection, companies reduce errors, improve compliance, and ensure teams always work with the most up-to-date information. This streamlining accelerates processes and cuts down on administrative labor.

Automated Task Management

Automating routine tasks like compliance reporting, batch record management, and regulatory submissions saves time and reduces errors. AI shortens the time needed to gather, validate, and submit data, allowing teams to focus on higher-value tasks such as innovation and strategic decision-making. This boosts productivity and ensures deadlines are consistently met.

Proactive Asset Management

With real-time asset management, AI monitors equipment lifecycles, wear and tear, and expiration dates. Automated alerts notify managers when assets need replacement or stock is running low, minimizing downtime, preventing costly mistakes, and ensuring uninterrupted production.

Enhanced Compliance and Audit Readiness

AI also enhances compliance and audit readiness by automating audit trails, generating comprehensive reports, and tracking every step of the drug development process. This reduces human error, lowers regulatory penalties, and ensures smoother audits.

Streamlining with Connect™ CMC and CPV: A Two-Pronged Approach to Efficiency

Connect™ CMC: Accelerating Drug Development

Connect™ CMC enhances efficiency during the critical pre-commercial stages of drug development. By integrating data across the entire CMC lifecycle, it automates key tasks like data processing, batch genealogy, and compliance reporting. This minimizes manual intervention and frees up time for teams to focus on high-value tasks.

  • Automating Batch Genealogy: Connect™ CMC simplifies batch data tracking and contextualization, reducing human error and ensuring full traceability from start to finish. This automation saves time and ensures data accuracy, which is essential for clinical drug development.
  • Digitizing Paper Batch Records: Connect™ CMC automatically extracts data from Paper Batch Records (PBRs), speeding up analysis and decision-making. This reduces manual data entry and increases overall productivity.

Connect™ CPV: Real-Time Process Optimization

Connect™ CPV  is designed for continuous process verification (CPV), offering real-time monitoring and compliance assurance throughout pharmaceutical manufacturing. It automates traditionally manual processes, significantly cutting both time and costs.

  • Automated Data Connectivity: Using AI-driven data mapping and automatic product genealogy, Connect™ CPV integrates data from multiple sources, reducing labor costs and boosting efficiency.
  • Real-Time Release: With continuous quality control powered by AI insights, Connect™ CPV allows for the real-time release of products. This reduces time-to-market while ensuring that all regulatory standards are met.
  • Automated Reporting: Connect™ CPV provides automated reports for compliance filing, leveraging all data sources to minimize errors. This ensures accurate, consistent compliance documentation essential for regulatory adherence.

Both Connect™ CMC and Connect™ CPV enhance pharmaceutical operations by automating critical tasks like data collection, compliance reporting, and batch monitoring. This shift reduces manual workload, enabling teams to focus on strategic initiatives that improve efficiency and product quality.

These products ensure seamless integration throughout the drug development and manufacturing process, maintaining compliance with regulatory standards while optimizing operations. With centralized data and streamlined processes, Connect™ CMC and Connect™ CPV help pharmaceutical companies reduce costs, adapt to regulatory changes, and drive long-term growth.

Explore how Connect™ CMC and Connect™ CPV can transform your operations. Contact us today!