QUALITY AND CHARECTERIZATION OF PRODUCTS
The characterization of various bulk drugs is vital to help build quality in to the drug product without compromising on its chemical and physical properties. Further, this process ensures that the drugs offer compliance, consistency, processability, functionality and above all stability.
Based on the formulation requirement (e.g.: solid dosage forms, liquid dosage forms, etc.), the Preformulation studies are conducted to determine the physico-chemical properties such as solubility at various pH, temperatures and solvents.
PRODUCT DEVELOPMENT STRATEGY EVALUATION
The Product development strategy lays emphasis on integrating the biophysical and biochemical characterization of your molecule with the final product formats, thereby developing a formulation that will ensure stability and offer compliance.
LAB SCALE DEVELOPMENT
In order to test the dosage formals integrational properties or co-efficiency with that of the bulk drug, or to obtain various regulatory clearences, MEDCHEM provides various bulk drugs that are developed as Lab scale batches.
DEVELOPMENT OF PRODUCTS AND ITS GRADING
A successful drug is the one that bonds well with the respective Pharmaceutical Ingredient. Hence, its development too is a very crucial process. The drug when integrated with the formulations has to offer optimum dosing compliance.
SCALE-UP / PROCESS OPTIMIZATION
Since the Lab-scale batches are tested and validated for stability and compliance, the process of Scale-up through technology transfer ensures that the same methods and processes are maintained throughout the large-scale manufacturing process.
STABILITY STUDIES AND PRODUCT DEVELOPMENT REPORTS
Our Stability studies are well documented and specific formulation related questions, such as formulation optimization stability, re-formulation, and primary-packaging queries, are regularly addressed as per client requests.