← Business Planning
Target Product Profile as the development brief
Formulation work starts from the Target Product Profile and constraints that came out of Business Planning: versioned, queryable, and connected to the molecule's commercial context.
The rationale, preserved from formulation to filing
Product Design is where a Target Product Profile becomes a manufacturable product. Most operations lose half the rationale between formulation work and the dossier that describes it because the work happens in lab notebooks and the dossier happens in templates. Krevyos closes that gap structurally.
- Domain owner
- Head of Formulation · Process Development · Tech Transfer Lead
- Product types
- Solid oral · Liquid · Sterile injectable · Inhalation · Topical · Modified-release
- Development phases
- Pre-formulation · Formulation development · Scale-up · Process validation · Tech transfer
Capabilities
Formulation development and excipient selection
Each formulation iteration carries the rationale, the data behind the choice, and the link to the eventual Module 3 narrative so the dossier writes itself from the work, rather than being reconstructed after the fact.
- Formulation development
- Excipient selection
Process design and scale-up
Process parameters, scale-up rationale, and process validation evidence live as connected records so a tech transfer to a second site doesn't require re-explaining the process.
- Process design
- Scale-up
Stability protocols and ICH Q1A execution
Stability studies tied to the formulations, batches, and packaging they describe with shelf-life conclusions traceable to the underlying time-course data, so an authority question on shelf life is a query against the protocol that produced it, not a reconstruction from archived studies.
- Stability protocols
- ICH Q1A
Tech transfer and site qualification
Transfer protocols, comparability studies, and site qualification work captured as a continuous record across the sending and receiving sites not as a project file that goes cold.
- Tech transfer
- Site qualification
Design history and decision rationale
Every formulation decision: what was tried, what worked, what was rejected and why: preserved as part of the operation, available to RA when a deficiency asks why a specific excipient was chosen.
- Design history
- Decision rationale
Touchpoints
→ Analytical Development
Specifications and method development
Each formulation variant carries its analytical methods and specifications as connected records so changing a formulation surfaces the method work it implies.
→ Quality Management
Process risk and CAPA linkage
Process failures, deviations, and CAPA actions during development carry forward into the validated process so post-launch quality work has the full development context.
→ Organizations & Resources
Tech transfer to CDMOs
When formulation work transfers to a CDMO, the partner inherits the live process record rather than a static PDF that ages from the moment it's sent.
Outcomes
- −50%(indicative)
Time from formulation lock to Module 3 draft
The narrative is generated from the work rather than retyped from it.
- +2×(indicative)
Formulation variants explored per development cycle
The cost of trying another variant drops when each one's rationale is captured structurally: exploration replaces commitment-to-the-first.
Rationale lost between development and dossier
Every formulation decision is part of the same record the dossier describes: no translation, no drift.
- 100%(indicative)
Tech transfer artifacts preserved across sites
Receiving sites inherit the live development record, not a static project file.
Figures marked indicative are directional benchmarks against comparable generics operations; per-customer numbers replace them in working sessions.
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