Drug Development and Regulatory Consultant

Team Credentials

Our team members have played key leadership role in shaping many top pharma companies by formulating, participating and executing the strategies to desired results.

Some of the notable credentials of our team are -

Our team has experience of filing about 150 ANDA products across a range of dosage forms like solid orals, liquid orals, parenterals, OINDP etc.
Completed CFC to HFA propellant transition of entire MDI product range for one company wherein 13 HFA based MDI products were developed for domestic market.
Development of about 15 DPI products for various companies for domestic market.
Development & approval of a no. Of MDI and DPI products for ROW market including ASEAN market.
2 Nasal Spray products were developed and filed for US Market.
3 Nasal Spray products including one suspension based product were developed for Brazil.
One MDI formulation developed for LATAM.

Successfully faced USFDA audit for Nasal Spray products without any deficiencies.
Successful commercial mfg. Facility set up for MDI and DPI products for one of the top 5 Indian pharma company.
Commercial mfg. Facility designing, installation, commissioning for MDIs for one Indian Company.
MDI & DPI product development lab designing, installation and commissioning for advanced markets for a top 5 Indian Pharma company.
The team has experience of regulatory plant audits like FDA, MHRA WHO etc.
The analytical team has done validation, process control and handling of regulatory agencies queries for successful product registration in all markets.
Our team has experience in generating & providing high end analytical data for creating non-infringing formulations.