Regulatory Requirements for conduct clinical trials in USA

What kind of Regulatory Requirements for the conducting clinical trials in USA? like, Which kind of Forms needed & FEEs related requirments, checklist, etc.

Please refer USFDA website for Clinical Trials Guidance Documents.
For example please refer following guidelines on USFDA website,

21 CFR part 320 - Bioavailability and Bioequivalence study requirements (for generic drugs)
Good Clinical Practices -

Similarly you can refer ICH guidelines as follows, (
Good Clinical Practice, ICH-E6 (R2)
Similarly there are various guidelines of ICH E1, E2, E3 TO E20 for conducting Clinical trials. These are classified as “Efficacy guidelines” of ICH.

I can suggest that you can also conduct clinical trials in India for the purpose of Regulatory submission to USFDA for rheir assessment and approval to get marketing authorization of a new drug product for USA market.

Similarly, Bioequivalence studies of generic drug products (after expiry of their innovators’ patents) can be conducted in India. There are a few reputed CROs (Clinical Research based Contract Research Organizations) in India to conduct Bioavailabillity- Bioequivalence studies for generic drugs (as ANDA submissions), and Clinical trials (phase-1, 2, 3, & 4) for new drugs (as NDA submission)’ These CROs are several times inspected by USFDA Regulatory authorities and have approved the clinical trials and BA-BE studies conducted and submitted by them through sponsors.

For conducting Clinical trials and BA-BE studies these products should be developed and manufactured by the pharmaceutical companies who submit these drug products samples to the CROs. CROs conduct the clinical trials or BA-BE studies and submit the clinical reports to the pharma manufacturer who in turn include these reports in their NDA / ANDA applications along with other manufacturing information (CMC- Chemistry, Manufacturing & Control) and finally submits to the USFDA Regulatory authorities for their review and approval / marketing authorization.

1 Like

Thanks for your compliments. I appreciate for that.
For your knowledge there are handful of CROs (Clinical Research based Contract Research Organizations) in India who are conducting BA-BE studies of pharmaceuical (Generic drugs) products as well as Clinical trials of new pharmaceutical products satisfactorily and those were approved by international Regulatory authoroties.

I was working as Head QA & Regulatory in one such esteemed CRO, namely Lambda Therapeutic Research which is a multinational Indian CRO, based in Ahmedabd, Gujarat having their units in India, Poland, UK & USA. We had conducted over 4000 Bioavailability & Bioequivalence studies for different generic drug produts of several pharmaceutical companies for submission to USFDA, EMA, MHRA-UK, ANSM-France, OGYEI-Hungary, ANVISA-Brazil, WHO-Geneva, Turkish MOH, Thai MOH, CDSCO -India and other global regulatory authorities as a part of ANDA / Product dossiers submissions. Infact Lambda was the first Indian CRO to get the permission to conduct phase-1 Clinical trials in our country in the year 2005-06. Lambda has its own pathology laboratory (Clinical Laboratory) to analyse safety samples of human volunteers participating in Clinical trials and BA-BE studies as per International Regulatory requirements and is accredited by CAP, USA (College of American Pathologists) which is considered as a “Gold Standarad” in Medial field globally apart from NABL accreditation. We had several satisfactory GCP & GLP inspections by Regulatory authorities as mentioned above.

I strongly suggest, the key factor in Clinical Research is to selelct right CRO who are strictly following Quality standards and have credibility and integrity with the highest Regulatory authorities globally.

If you have any further questions please do write back to me on my personal email id [email protected]