GRAM Laboratories, Inc.
of our major strengths is in the efficient development of a clinically relevant
and more stable formulation. This is
made possible because of the knowledge gained from preformulation evaluation.
Formulation studies are customized to achieve the most appropriate formulation
in a timely and cost efficient manner. Based on the desired dosage form, key elements of formulation development studies are selected from the following list of studies.
with Manufacturing Components
with Primary Packaging Components
and Z-value Determination
Feasibility at various Fo
Cycle Development Studies
Qualification and Validation Studies
and Leachables Study
Moisture Stability Studies
Size Distribution Studies
and Emulsion Stability Studies
of Prototype Batches
Term Accelerated Stability Evaluation
Analysis of Stability Data
Draft Component Specification
Draft Manufacturing Process Specification
Draft Product Release Specification
Draft Product Stability Specification
SERVICES: Formulation Development