We serve four types of customers within the life sciences space: innovators, generics, OTC and distributors. Each has very unique needs, and we build our systems to address them elegantly. Please see what we have done below for each.
You hold NDAs and BLAs. Not many products, but each one is enormous, each changes often, and each is read closely by people who are paid to find problems.
Label lifecycle management
Two use cases: US labels and Canadian labels
US labels
The prescribing information sits with its Medication Guide, patient package insert, Instructions for Use and display panels as a single product record, with establishments and registrants attached to the products they belong to.
- Minor changes: your own team edits directly, in minutes, with no XML knowledge
- Extensive changes or a brand-new application: through the transformation process — ~95%+ of final SPL generated within minutes. We ship you the final version after QC
Canadian labels
My Canada Library brings the Standard Product Monograph onto the same platform as your US labels — same portfolio view, same editor, same audit trail.
- PDF to Standard Product Monograph automated, including the product metadata collection that normally has to happen before the real work can start
- Extensive changes or a brand-new monograph: through the transformation process — ~95%+ of final SPM generated within minutes. We ship the final version to My Canada Library after QC
- Incremental changes afterwards are something your own team does, with a full audit log of every change
- Validated against the engine we wrote for Health Canada's own rule set — all 79 rules — because no public validator for the SPM exists
Watchlists and alerts
A class-safety and competitive instrument
When a class-wide labeling change lands, you see it the day it lands — along with the actual wording every other holder in the class filed. Not a summary six weeks later from a consultant.
- Class labeling changes across your therapeutic areas
- Competitor label updates, new indications and safety additions
- Approval and supplement activity on your own products
Research
What has FDA already accepted?
That question decides what you write before you write it, and the answer is scattered across DailyMed, Drugs@FDA, the Orange Book and approval packages.
- Does the Warnings and Precautions section of any glucagon-like peptide-1 (GLP-1) receptor agonist label mention pregnancy or lactation?
- Which sodium-glucose cotransporter 2 (SGLT2) inhibitor labels carry a Limitations of Use statement under Indications and Usage?
- Which aromatase inhibitor labels specify a dose adjustment for renal impairment in Dosage and Administration? Exclude generics.
Reporting
Generated from the portfolio, not assembled from memory
Annual report support and full supplement history, produced from what the platform already holds about your products.
No single label in your portfolio is difficult. The volume is difficult, and so is the fact that everything moves when somebody else moves.
Label lifecycle management
Every ANDA mapped to the reference product it depends on
This is the part that matters most and the part nobody centralises. Each of your applications is held in the library alongside its reference listed drug and reference standard. Today that mapping usually lives in one spreadsheet maintained by one person, and it is the single point of failure in the entire operation.
- The RLD and RS mapping is a first-class part of your library, not a side table
- Routine changes handled in-house, in minutes
- Bulk onboarding of a legacy ANDA portfolio through the transformation process
Watchlists and alerts
Not “something changed” — which of your products are affected
Watch the reference products your applications depend on. When an RLD label changes, the platform does not hand you a notification and wish you luck. It names the products in your own portfolio that are now on the clock, because the mapping already exists.
- One reference label change resolved to every affected ANDA you hold
- Each with its own approval letter date and its own fourteen-day clock
- What other generics referencing the same product have filed, so you can see whether you are out of step
Illustrative example. Multiply this by a portfolio of several hundred ANDAs and it is most of a generics team's year.
Research
Portfolio-shaped questions, answered the same week
- Which kinase inhibitor products indicated for breast cancer lose US patent protection before 2030?
- Which reference listed drugs in the Orange Book published a labeling change in the last 12 months?
- How many approved ANDAs list imatinib as an active ingredient in the Orange Book?
Reporting
Blanket no changes certification without the December scramble
Across several hundred ANDAs at once, generated from the portfolio the system already holds rather than reconstructed across divisions every year.
Thousands of listings, a rigid panel format, and packaging that changes far more often than the science does — plus a large share of the portfolio approved under ANDAs, carrying the same reference-product dependency a prescription generic has.
Label lifecycle management
The whole SKU portfolio in one searchable place
Labeler, packager and private-label relationships are modelled as relationships rather than flattened into a name field, so the portfolio reflects how your business actually works.
- Bulk conversion rather than one label at a time
- Metadata pulled from an existing SetID or a drug name instead of keyed by hand across thousands of products
- Drug Facts panel structure under 21 CFR 201.66 handled by the platform
Watchlists and alerts
A portfolio-hygiene instrument
At your volume the risk is not a missed safety change. It is products that have quietly gone stale or inactive while still sitting in your system as current.
- Listings that have gone inactive in FDA's authoritative listing data
- Monograph activity affecting your actives
- Products drifting past their expected review cycle
Research
Knowing what you actually have on file
- Which OTC labels list acetaminophen in the Active Ingredient section and mention severe liver damage in the Warnings section?
- Which marketed OTC products still list oral phenylephrine as a nasal decongestant active ingredient?
- Which labelers market an OTC product listing ibuprofen 200 mg in the Active Ingredient section?
Reporting
Certification at SKU volume
Annual listing certification and blanket no changes certification are the single biggest scramble in an OTC year. Generated from the portfolio, they stop being one.
Repackager, relabeler, private label distributor, retail chain, institutional supplier — if you hold a labeler code, you authored that SPL and FDA holds you responsible for keeping it current. The clinical content belongs to the manufacturer upstream. That gap is a real obligation, it runs on its own legal clock, and almost nobody builds tooling for it.
Label lifecycle management
The chain from source to your label, stored rather than investigated
Every listing you own is held alongside the upstream manufacturer's NDC and SPL, so the path from origin registrant through original labeler to your own label is a stored relationship you can open — not a research project you run whenever someone asks.
- Your listings mapped to their source NDC and source SPL
- Your own private-label and relabeling declarations captured properly
- Changes handled in-house rather than routed back through a vendor
Watchlists and alerts
The day your source updates, you are behind. This tells you.
When the upstream manufacturer revises their label, your listing is immediately out of date and nothing in the market notifies you. You are under the same pressure a generics company is under, with far less recognition that the pressure exists — and on a different clock. Not the ANDA supplement window, but listing currency: material changes, a semiannual review in June and December, and an annual certification between October 1 and December 31. Miss it and the listing expires on January 1.
- Which listings are behind their source — in review cycles, not just elapsed days
- Which upstream manufacturers have published since your last update
- Listings already inactivated in FDA's authoritative listing data
- June and December reviews and the year-end certification window, across the whole portfolio at once
We built this because we went and looked. We analysed tens of thousands of DailyMed listings across more than a hundred distributor parent companies to understand exactly how, and how often, this breaks.
Research
Who is actually responsible for this listing?
- Which labelers publish an active prescription drug label listing metformin hydrochloride as an active ingredient? Name the proprietary drug name for each.
- Which prescription drug labels listing amoxicillin are marked inactive in the corpus?
- Which active prescription drug labels are published by a labeler whose name contains “repack”?
Reporting
The same obligations as anyone holding a labeler code
Listing certification and periodic reporting, generated from your portfolio rather than assembled by hand each year.