Preparing Regulatory Submissions is Tedious
Your colleagues design, plan, and execute numerous studies—process control and justification, forced degradation, fate and purge, method development and validation, toxicological assessment, and more. These studies demonstrate understanding, control, and safety of your processes and products, and must be communicated to regulatory authorities.
But preparing data for regulatory agencies can take months. Scientists must provide reports that conform to data integrity and quality assurance standards; most importantly, tracing summaries back to originating data.
Our software and knowledge management tools will accelerate and streamline your regulatory submission workflow by addressing current challenges.
Too Much Time Is Spent Querying, Gathering, and Transcribing Information
Because the data required for regulatory submissions is scattered, you need to use multiple pieces of software or ask colleagues to gather information. And it must be done quickly. Critical submissions and responses to health authority requests are time-sensitive. In some urgent situations, it’s faster to repeat experiments and analyses than to find the original data!
Analytical Data is Heterogeneous or Incomplete & Disconnected
Analytical data resides in many formats within various CDSs and vendor-specific databases, or it is abstracted to numbers and images. Data may also be disconnected from its experimental context and associating experimental and sample context for important datasets is painstaking and manual.
Material for Toxicological Studies is Lacking
Perhaps the material is difficult to isolate or challenging to synthesize. Either way, a lack of material for early toxicological assessment slows project progress. Experiments are also time and labor-intensive.
Centralize data management so you can find the information you need when you need it. With our software, your project teams can work with all their analytical and chemical information in one place and you only need to search for it in one place.
- Access LC/MS, GC/MS, NMR, Raman, IR data, and more in one software environment
- Search with chemically intelligent queries—use structural, spectral, chromatographic, and metadata search parameters
- Interrogate and re-process data instantly if/when necessary
With immediate access to the information you need, responses to regulatory authorities will be faster than ever.
You need to demonstrate that decisions made are based on clear reasoning. We make it easy for your subject matter experts (SMEs) to store all the relevant information together. With our software, you can easily locate, understand, and use data without needing explanations from colleagues.
- Review interpreted, annotated spectra and chromatograms with integrated chemical structure
- Know the rationale behind control methods with decisions stored within the method development project
- Access route scouting data complete with impurity fate and purge, and connected analytical data
- Store all relevant data and decision points in one place so you can retain experimental context and ensure data integrity
Our software provides digital records of all supporting, originating data—both digital structures and analytical data. With all the data consistent and at your fingertips you will prepare submissions faster than ever.
- View spectra and chromatograms for all analytical techniques and vendor formats
- Copy/paste spectra, chromatograms, structures, and textual data directly to Word, Excel, or PDF
- Interrogate interactive spectra and chromatograms and reprocess instantly as needed
We help your toxicologists quickly assess the safety of impurities and degradants with predictions directly from the structure. Use the data as part of your ICH M7 workflow and prepare regulatory submissions.
“We used the analysis results of Percepta Impurity Profiling Suite as evidence for submissions to regulators in China and abroad for acceptance. ”
“I was a lot more efficient [with Luminata]. I wasn’t going back and trying to manage ‘Which Excel file was that data in? Where was [the original data] actually located? Was this completely filled out or not?’ I’d say that I was 33% more efficient… because I didn’t have to keep going back, searching for something.”
“...we have reduced the loss of interpretation information and expensive retesting of samples…the QbD approach to method development aided by ACD/AutoChrom provides a return on investment within a short time.”
“Using Luminata one person in two weeks did what would normally take 4 people 3 months to do.”