SURF Smart Solutions
PRESSURES MOUNTING • PROFITS FALLING

FIND IT • ACT ON IT

The pressures facing regulatory and compliance professionals are greater than ever before; heightened scrutiny, delayed submissions, slow product approvals and increased litigation are all compounded by shareholder demand for greater profits.

NewLane SURF© Regulatory Compliance Solutions enable companies to leverage information from structured documents and unstructured content, harmonize global initiatives, speed regulatory approvals and mitigate legal exposure.

DID YOU KNOW?
"69% of your colleagues believe that less than 50% of their organization's information is findable"
— AIIM

SOLUTIONS THAT MATTER • TANGIBLE RESULTS

Faster time-to-market
Accelerate discovery, development and commercialization by gaining real-time visibility and Findability into the quality and submission processes in all areas of the business.
Reduce Costs
Lower the cost of regulatory compliance through more effective preparation and collaboration of Submission Documents for IND and NDA submissions.
Improve Processes
Proactively identify, track and resolve quality and compliance issues by leveraging information to make informed decisions based on all available information.
Reduce Noncompliance Risk
Have all available data accessible for real-time investigations, audits, monitoring and pharmacovigilance.


Real World Results

THE CHALLENGE

A multi-national Pharmaceutical company had successfully launched a highly effective new drug however the patent behind the drug was in question. The company needed a way to prove their rights and protect their IP from the challenge.

 

THE ORIGINAL PROCESS

The information that was needed to successfully defend against the complaint was contained in multiple data sources. RDBMS, LIMS, File Shares and paper all contained key components of information.

THE NEWLANE SOLUTION

An overall taxonomy and structure was developed for the information. The various systems were organized and brought under that structure and the paper information was scanned and indexed to allow for quick and easy retrieval.

 

THE NEWLANE RESULT

The company was able to show their development efforts and research notes validating their claim to the drug. Additionally, by effectively organizing their information and being able to search for the specific relevant information requested by the plaintiff they were able to prevent a full scale discovery from taking place.

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