In Q3 2022 Lamda successfully concluded the mock audit regarding FDA readiness for our state-of-the-art GMP certified analytical laboratory in collaboration with a leading compliance consulting services company.

Apart from compliance of our quality system and standard operating procedures to US requirements, our workforce is capable of undertaking new product ANDA and 505(b)(2) developments for the US territory.

More specifically, we fully support analytical method development and validation according to US regulatory requirements along with formulation development based on the experimental Quality by Design (QbD) principles.