Covid-19

Regulatory Automation (RegMation), it’s matter of when!

Regulatory Automation (RegMation), it’s matter of when!

Constant Regulatory Changes, Productivity Pressures, headcount Questions and now Covid-19 Disruption. By understanding these considerations, Bio-Pharmaceutical companies should pursue Regulatory Automation opportunities more assertively and in small realistic phases instead of waiting.

By leveraging machine intelligence, Regulatory teams can solve efficiency problems, gain better insights with contextual data, and save time (from manual grunt) to take up innovative projects.

Some of the White Paper highlights:

  • What is RegMation?
  • Which Functional Processes are good for Regulatory Automation
  • Which processes can be integrated
  • Benefits of Regulatory Automation

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Reduce Labeling Content, QC & Tracking Challenges

Reduce Labeling Content, QC & Tracking Challenges

Labeling errors, mix-ups and misbranding are among the most prevalent labeling errors that can lead to product recalls. Most labeling activities (content, local labels QC, publishing) are still predominantly manual putting a dent on productivity and increasing costs.

Most of this is a known story for labeling teams. Labeling leadership should move towards digital & automation and away from “same-old document” world. COVID showed all companies the overall possibilities, opportunities and risks as well. So labeling teams should not aim to go back to “normal” status-quo when it comes to labeling.

This whitepaper discuss about the benefits of labeling automation & digitization in:

  • Label Content Management & Life cycle automation
  • Labeling Compliance automation
  • Labeling publishing automation
  • QC Review Process and more...

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Ensuring Compliance with Drug Accountability with IRT

Ensuring Compliance with Drug Accountability with IRT

Drug accountability is a need of the hour to ensure regulatory compliance during clinical trials. IRT tends to be of utmost help at this time ensuring patient safety and helping you in earning approval. This whitepaper highlights some key areas of compliance that can be ensured along with drug accountability with the help of IRT.

Along with this, there are a few other things that this paper covers such as:

  • Challenges in managing paper-based drug accountability
  • How does IRT help?
  • The future prospects

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Med Devices Regulatory teams, don’t go back to NORMAL

Med Devices Regulatory teams, don’t go back to NORMAL

Cultures within Medical device organizations are changing due to the current COVID situation. It is a great time to embrace data-driven culture change as this would soon become the norm to attain success. Medical Device Regulatory teams are trying to shift to the data-driven culture and this whitepaper highlights the need of technology and analytics for better compliance.

Some of the crucial areas that this paper highlights include:

  • Role of Senior Leaders
  • Culture Change Programs
  • Technology Adoption in Every Job

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Medical Device Regulatory systems, more critical than you think

Medical Device Regulatory systems, more critical than you think

Regulatory teams are under continuous pressure to maintaining a balance in the system of information management. They have to stay at par with the changing regulatory environment but at the same time, it is necessary to ensure that new products reach the market in a shorter time. If stability is not restored on time then it might lead to some serious risks and losses. You will be getting a complete view of the challenges present in the medical device regulatory systems and at the same time understand how a proper regulatory system can potentially benefit you.

Challenges:

  • The necessity of independent tools raises costs.
  • Difficulty in keeping track of data leads to loss of tracks.
  • Impact Analysis on new projects.

Benefits:

  • You end up having the right dossier.
  • No need for renewal of licenses.
  • Get your products digitally labeled.

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