Formulation Development
Budget: ₹12,500 – ₹37,500 INR
I am moving an existing formulation into the scale-up and commercial-manufacturing phase and need an experienced formulation scientist or process engineer who can guide each step while keeping long-term product stability front-of-mind.
Where I am now
• Laboratory-scale batches have proven the concept.
• Preliminary specs and analytical methods are in place (HPLC, dissolution, moisture, etc.).
What I need from you
1. A pragmatic scale-up strategy that translates my bench process to pilot and commercial equipment without compromising critical quality attributes.
2. Detailed protocols for accelerated and long-term stability studies (ICH zones), including container/closure selection, pull schedules, and acceptance criteria.
3. Input on process parameters, CPP/CQA mapping, and any DoE you feel is essential to tighten the design space.
4. Clear, GMP-ready documentation: batch records, validation plans, and stability reports that will satisfy regulatory reviewers.
Timing & collaboration
There is no hard deadline, so quality and regulatory robustness take priority over speed. We can schedule milestones around major deliverables and adjust as data come in.
If you have successfully taken oral solid or parenteral products from lab to plant and can show audited stability programs that passed scrutiny, I would like to hear how you would approach this project.
Where I am now
• Laboratory-scale batches have proven the concept.
• Preliminary specs and analytical methods are in place (HPLC, dissolution, moisture, etc.).
What I need from you
1. A pragmatic scale-up strategy that translates my bench process to pilot and commercial equipment without compromising critical quality attributes.
2. Detailed protocols for accelerated and long-term stability studies (ICH zones), including container/closure selection, pull schedules, and acceptance criteria.
3. Input on process parameters, CPP/CQA mapping, and any DoE you feel is essential to tighten the design space.
4. Clear, GMP-ready documentation: batch records, validation plans, and stability reports that will satisfy regulatory reviewers.
Timing & collaboration
There is no hard deadline, so quality and regulatory robustness take priority over speed. We can schedule milestones around major deliverables and adjust as data come in.
If you have successfully taken oral solid or parenteral products from lab to plant and can show audited stability programs that passed scrutiny, I would like to hear how you would approach this project.