WHY CHOOSE US
We are a group of Quality practitioner`s with over 25 years of experience in the field of Analytical Development, Pharmaceutical regulations and Audit Compliance.
Our team is competent to deal with Analytical developments, Quality Systems (QA/QC) for both Active Pharmaceutical Ingredients (API) and Finished products(FP). We ensure that the activities are in-line with the regulatory requirements like cGMP, ICH Q11, M7, etc.
We provide Specialized Pharma Analytical Consultancy to Pharmaceutical industry across various functions viz, Research & Development, Analytical Development, Quality control, Quality Assurance & Regulatory affairs.
We deal with operations like analytical method Development, Validation, Data integrity assessment, Control strategy, Specifications, GTI evaluation, GAP analysis, DMF /ANDA Review and Compilation, Deficiency response and Customized Technical Trainings.
We have multiple connects for all pharma solutions, starting from development to approval.
Technical Expert
Active Pharmaceutical Ingredient
Mr. Mahesh Poojari
Founder
20+ yrs in Analytical Development with Expertise in Control Strategy and Impurity Profiling. 5 yrs as Independent Pharma Consultant – Quality, Technical & Regulatory
Expertise
HPLC Method Development & Troubleshooting, Quality Control, Data Integrity Assessment, Customized Trainings, Technical & Regulatory aspect of Pharmaceuticals.
Technical Expert
Physico Chemical Characterisation
Dr. K. Shashirekha
Co-Founder
20+ yrs in Analytical Development with Expertise in Control Strategy and Impurity Profiling. 5 yrs as Independent Pharma Consultant – Quality, Technical & Regulatory
Expertise
Solid State Characterization – Polymorphism, Particle Characterization, Pre-formulation Studies & Reverse Engineering for new Product Development. Experience of Depositions in Polymorph Patent Litigation.
Technical Expert
Active Pharmaceutical Ingredient
Dr. Santosh Sadaphule
Co-Founder
21+ yrs in Analytical Development with Expertise in GC & GC/MS Technique. Complete Knowledge in Analytical Development Activities for Active Pharmaceutical Ingredient – DMF Filing and Post Filing Activities
Expertise
GC/GC-MS Method Development and troubleshooting. Regulatory Aspect of Pharmaceuticals, cGLP, GMP, FDA Guidelines and Standards
Technical Expert
Formulation
Mrs. Kalpana Verma
Lead Consultant
20+ yrs in Analytical Development and Validation for Formulation as well as Raw Material. 5 yrs. as Independent Pharma Consultant – Quality, Technical & Regulatory
Expertise
Formulation analytical method development & validation, Data integrity. Extensive experience in compliance with Good Laboratory Practices (GLP) and Good Manufacturing Practice (GMP) guidelines.