Services / Scope
Formulation development: Any dosage form, from any source of medicine like Synthetic, Herbal, Neutraceuticals & Cosmetic preparations
- Oral solid dosage form like a tablet, granules, capsules, dry syrups
- Liquid dosage forms
- Parenteral formulations
- Ointments and creams
Any market – US/ EU/ Canada/ Australia, ROW,
India
Partial development to trigger the product the registration process of ANDAs
Development by DOE and QBD
Product registration for all dosage form across the globe
Technology development for pharma and allied healthcare companies
DSIR approval to small R&D center, ensuring huge taxation benefits
IP support & NIS report for API & formulations & new technology
Complete regulatory support for drug product & drug substance
Product and process validation
Analytical method development and analytical method validation
Product technology transfer in India & overseas
Content writing of dossiers, all modules
Product registration and filing in the regulated market, semi-regulated market & in India.
Offshore CQA & QA support for plants, to upgrade their quality system
Trained manpower for CQA/ QA/ Marketing
Offshore technology transfer in India & internationally by trained personnel
Troubleshooting
Training
Project management
Regulatory query solving
Preclinical study support on animals for NCEs & NDA filing
Clinical support by providing our pilot GMP area to manufacture the clinical batches for pilot bioavailability & pilot bioequivalence study
We provide an end-to-end solution for a product development & product lifecycle
management
We have a state-of-the-art facility in Mumbai, India, dedicated to OSD products with a GMP area for manufacturing the batches for pilot BE studies & clinical studies
- In-house scale-up studies by QBD approach.
- Our facility supports the study of batch sizes starting from 200gm to 250kg
