The data is measured. Nobody has evaluated it yet.We deliver the report. You release it.
Structure confirmation, impurities, stability to ICH Q1E, ICH M7, solubility, DoE and synthesis routes for pharma, CDMOs, contract labs and chemicals. Checked by PhD scientists.
30 minutes on Microsoft Teams with the CovaSyn team. If it is not a fit, we will say so.
Evaluation report
Shelf life per ICH Q1E
Result
24 months supported, limit reached after 31 months.
- Question
- Do the stability data support a 24-month shelf life?
- Method
- Regression per ICH Q1E, 95 % confidence limit, poolability tested
- Assumptions
- Storage at 25 °C and 60 % RH, three batches, assay and degradant B
- Limits
- No statement on storage outside the tested conditions
Reviewed
PhD scientist, CovaSyn
Approval
Your expert
Your position is open.The evaluations are not.
The analytical position has been open for months, your stability colleague is on parental leave, and in November three studies hit a time point at once. We evaluate what comes in during that time, with reasoning and calculation path. Nobody has to be hired or onboarded.
Where it is stuck right now
Which evaluation is sitting on your desk?
Analytics, quality, development and process. Each tile leads to a typical case with the data we need and what the report contains.
Confirm a structure from NMR, MS and IR
The spectra have been sitting on the desk for days, and nobody has time to assign them properly.
See the caseNarrow down an unknown peak from LC-MS
A peak has appeared above the identification threshold, and we do not know what it is.
See the caseStability to ICH Q1E and OOT
One result in our stability study looks different from the earlier ones, and we don't know whether it's a trend or just scatter.
See the caseClose an OOS investigation
We have an OOS result, the batch is on hold, and the investigation hasn't reached a conclusion for weeks.
See the caseCrystallization and solubility
Our crystallization yield is too low, and we don't know whether to cool or use an antisolvent.
See the caseSynthesis route to the target molecule
We have the target structure, but no route we want to rely on yet.
See the caseHPLC starting method and method transfer
We need a new HPLC method, and scouting is eating up weeks of instrument time.
See the caseProcess capability Cpk and Ppk
Our Cpk is too tight, and we don't know which parameter drives the variation.
See the case
How an assignment runs
From data set to a report you can release.
Nothing is installed on your side. You need the data set, the question and 30 minutes.
1. Discuss the case
30 minutes on Microsoft Teams about the compound, the question and the data. Afterwards you know whether we take the case and which data is missing, and you receive the offer in writing.
2. Hand over the data
Raw data and context, such as spectra, chromatograms, stability tables and the specification. The report typically arrives within 5 working days once we have your complete data.
3. Review and release
The report states its data basis, calculation path and limits. Your reviewer checks it against the raw data, and you release it in your own quality system.
What you get
A report your reviewer can check against the raw data.
The answer
Assignment, structure, classification, shelf life, route or method, in one sentence at the top of the report.
The reasoning
Every step with the input data it rests on and the calculation behind it.
The regulatory reference
Where it matters, with a reference to the guideline, such as ICH Q1E, ICH M7, ICH Q2(R2) or USP <621>.
The limits of the statement
What the evaluation shows and what only a measurement in your lab can confirm.
The next measurement
Where the data falls short, the report states which measurement settles the question, such as an HSQC, a reference standard or another stability time point.
Ready for your files
As a PDF with version and date, structured to attach to a deviation, OOS report or development report.
Security and data protection
Your data stays protected.
- Hosted at Hetzner in Nuremberg, data kept in the EU
- Your data used only for the agreed purpose
- GDPR Art. 28 DPA, ready to sign on request
- Deletion on request within 30 days, backups included
- Source reference and calculation path for every result
FAQ
Frequently asked questions
Which evaluations does CovaSyn take on?
In analytics we confirm structures from NMR, MS and IR and narrow down unknown impurities from LC-MS. In quality we evaluate stability to ICH Q1E, assess impurities under ICH M7, run forced degradation with mass balance and support OOT, OOS and E&L. In development it is solubility, crystallization, design of experiments and the synthesis route to a target molecule. Add to that HPLC starting methods, method transfer and process capability as Cpk and Ppk.
Who checks the result, and who releases it?
A scientist with a PhD checks every report before it leaves our hands. We are responsible for the evaluation and its reasoning. Assessment and release are yours, under your quality system.
How does working together start?
With an initial call, 30 minutes on Microsoft Teams, about the compound, the question and the data. Afterwards you know whether we take on the case, which data we need and when the report will arrive. Nothing to install or set up.
Can we use the report in a GMP environment?
Yes, as the basis for your assessment. Every report states input data, calculation path and version. Where your supplier management requires it, we sign a quality agreement, answer the supplier questionnaire and are available for an audit.
Where is our data kept?
Hosted at Hetzner in Nuremberg, data kept in the EU. Your data used only for the agreed purpose. Deletion on request within 30 days, backups included.
How reliable are the results?
Every report is checked by a scientist holding a doctorate before it is sent. Every statement is in the report with its data basis, calculation path and limits, verifiable against your raw data. Where the data fall short, the report names the measurement that settles the question.
Next step
Which evaluation is waiting on your desk?
30 minutes on Microsoft Teams. Bring the case, ideally with a sample data set. Afterwards you know whether we take it on, and you have the offer in writing.