Filings we handle end to end
Saideep Pharma Solution files regulatory applications on behalf of pharmaceutical, API, medical device, cosmetic and food companies in India. Work covers CDSCO approvals, State Licensing Authority manufacturing licences, FSSAI import clearance and WHO-GMP certification, from gap assessment through to certificate in hand.
CDSCO regulatory consultancy
Strategy, dossier review and end-to-end filing for pharmaceuticals, APIs, medical devices, cosmetics and food.
SUGAM, NSWSDrug import registration
Form 40 applications, plant master files and site registration through to the Form 41 certificate.
Form 40, Form 41, Form 8 / 8A, Form 10 / 10ANew drug approval
Applications under the New Drugs and Clinical Trials Rules, 2019, including FDC submissions.
CT series, Form 29BE NOC applications
Assistance in preparing, filing and following through bioequivalence study NOCs to subsequent approval.
Form 29, Ethics CommitteeBA/BE centre approval
Facility readiness, SOP review and application support for bioavailability and bioequivalence centre registration.
CDSCO inspection, Ethics CommitteeCosmetic registration
Import registration under the Cosmetics Rules, 2020, from label review to the COS-2 certificate.
Form COS-1, Form COS-2FSSAI approval and import NOC
Nutraceutical and food product registration, import NOC and export permission documentation.
FSSAI Central Licence, FICS, IECWHO-GMP certification
Infrastructure development against WHO TRS guidance and revised Schedule M, plus amendment filings.
WHO-GMP, COPP, Schedule M