We have a line of CTD Dossiers ready for USFDA-ANDA submissions, inclusive of bio-equivalency studies. We also supply semi-finished DC granules in Pellet format for easy encapsulation and tabletization.
LODAAT works with leading manufacturers to produce the best quality innovative products.
We sell ANDA submission CTD-format Dossiers; DMF grade semi-finished pellet material for tabletization and encapsulation; and technology transfer training from our accredited science team.
With our designated partners, we also have over 10 years building USFDA compliant pharmaceutical and nutraceutical facilities and can assist in all areas of a Turn-Key buildout.
Our goal is to insure that our customers can manufacture the highest quality products that pass all local regulatory submissions.
Our India based lab capabilities include: wet lab, instrumentation lab, and microbiology section. Formulation development for blends as well as compression products is part of the process.
We have a team which has developed WHO-GMP and USFDA facilities. We use surveys, interviews, and observation to conduct a comprehensive case study and Project plan analysis audit. Upgrade your facility to the highest regulatory standard.
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