I introduce our organization stabicon life sciences, a focused cro, specialized in the area of analytical method development & validations, stability and formulation development programs in accordance with the guidelines of various regulatory bodies. Meanwhile we successfully went through nabl and who geneva analytical lab audits recently and expect to get their approvals soon. I am attaching our company presentation for your kind perusal. We are keen to establish business relations with your company in the fields mentioned.
I introduce our organization stabicon life sciences, a focused cro, specialized in the area of analytical method development & validations, stability and formulation development programs in accordance with the guidelines of various regulatory bodies. Meanwhile we successfully went through nabl and who geneva analytical lab audits recently and expect to get their approvals soon. I am attaching our company presentation for your kind perusal. We are keen to establish business relations with your company in the fields mentioned.
Preformulationreformulation for solid, semi solid (only orals) and topical formulations dosage form, pre-clinical formulation, prototype development (lab scale) batches and tech transfer support. This consolidation will reflect the conscious effort made by us to make prudent choices of further trimming your R&D expenditure and investment. Also gives you place where change is anticipated and facilitated, not where change requires sign-off at several levels and can take weeks or months to deliver the necessary information for decision-making and product registration.
Preformulationreformulation for solid, semi solid (only orals) and topical formulations dosage form, pre-clinical formulation, prototype development (lab scale) batches and tech transfer support. This consolidation will reflect the conscious effort made by us to make prudent choices of further trimming your R&D expenditure and investment. Also gives you place where change is anticipated and facilitated, not where change requires sign-off at several levels and can take weeks or months to deliver the necessary information for decision-making and product registration.
1. Pre clinical Stability study Management
These studies begin with preclinical phase to support animal toxicology.
2. Phase I stability study Management
In Phase I, studies are used to establish drug excipient compatibility to assist in formulation development and ensure the stability of the API as formulated in the Clinical Trial Material (CTM).
1. Pre clinical Stability study Management
These studies begin with preclinical phase to support animal toxicology.
2. Phase I stability study Management
In Phase I, studies are used to establish drug excipient compatibility to assist in formulation development and ensure the stability of the API as formulated in the Clinical Trial Material (CTM).
Stability Studies require methods which are stability indicating and these methods must stand up to stringent cGMP regulations and regulatory scrutiny. Stabicon’s combination of experienced analytical team, team leaders and their cGMP training and cGMP experience will give you unmatched quality of analytical methods validated to stringent regulatory standards to meet any filling requirements.
Stability Studies require methods which are stability indicating and these methods must stand up to stringent cGMP regulations and regulatory scrutiny. Stabicon’s combination of experienced analytical team, team leaders and their cGMP training and cGMP experience will give you unmatched quality of analytical methods validated to stringent regulatory standards to meet any filling requirements.
Our Microbiological laboratory is modern and fully equipped to perform tests to support different types of Stability programmes. The facilities are fully cGMP compliant and include a Class 100 Bio safety cabinet.
Our Microbiological laboratory is modern and fully equipped to perform tests to support different types of Stability programmes. The facilities are fully cGMP compliant and include a Class 100 Bio safety cabinet.
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