Your regulatory partner
Regulatory consultants for pharma, devices & cosmetics in India
We assist in preparing, filing and closing out CDSCO and FSSAI approvals for manufacturers and importers.
Where we file
- CDSCO, New Delhi
- Drugs & devices
- Cosmetics import registration
- COS-1, COS-2
- Medical device import
- MD-14, MD-15
- FSSAI product approval
- Import NOC
- WHO-GMP certification
- Schedule M
Trusted by
What we do
Filings we handle end to end
Each engagement starts with a gap assessment against the current rules, so queries get answered before the reviewer raises them.
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 Committee
Cosmetic 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
Regulatory specialists, not generalists
Saideep Pharma Solution is a team of regulatory consultants with long service inside the Indian pharmaceutical industry.
We find the gaps in a dossier before it reaches the reviewer. That is the whole job. Files that go in complete come back approved instead of coming back as a query letter, and the difference is usually measured in months.
Alongside filing work, we run channel development across India and arrange research facility tie-ups for companies entering a new category.
How an engagement runs
Gap assessment
We read your existing documentation against the rules that apply today and send back a written list of what is missing, what is outdated, and what will draw a query.
Dossier compilation
Technical documents, stability data, labels, site master file and undertakings assembled in the format the authority expects, not the format you happen to have.
Filing
Submission through SUGAM, the National Single Window System or the relevant State portal, with fees, annexures and digital signatures handled on your behalf.
Query response
Deficiency letters answered within the response window. We track the file and keep you told where it sits, rather than waiting for you to ask.
Licence in hand
Certificate delivered with the renewal and post-approval obligations mapped out, so the next cycle does not start from zero.
Sectors we work in
Four regulators, four rule books. We work across all of them, which matters when a single product straddles two.
Pharmaceuticals
Formulations, new drugs, FDCs, manufacturing and import licences.
Active ingredients
Bulk drug registration, import permission and site documentation.
Medical devices
Class A to D registration and import licences under the Medical Devices Rules, 2017.
Cosmetics
Import registration and labelling compliance under the Cosmetics Rules, 2020.
Food & nutraceuticals
FSSAI product approval, import NOC and export documentation.
Companies we have filed for
Manufacturers, importers and device companies across India.
Questions we get asked
Do I need a consultant, or can I file with CDSCO directly?
You can file directly. Companies with a standing regulatory affairs team often do. Consultants earn their fee where the category is unfamiliar, where a previous filing drew queries, or where the applicant is an overseas manufacturer who needs an Indian authorised agent to hold the licence.
How long does cosmetic import registration take under the Cosmetics Rules, 2020?
Registration is applied for in Form COS-1 and granted in Form COS-2 by the Central Licensing Authority. Most of the elapsed time is spent on label compliance and on the free sale certificate reaching CDSCO in an acceptable, legalised form, so getting those right before filing is the biggest lever on the timeline.
What is the difference between Form 41 registration and an import licence?
They are two separate steps. Form 40 is the application to register the overseas manufacturing site and its products, and Form 41 is the registration certificate that comes back. Only once you hold the Form 41 can you apply for the import licence itself, in Form 8 or Form 8A, which is granted in Form 10 or 10A.
Do we need WHO-GMP certification to export?
Not universally, but many importing countries ask for a WHO-GMP certificate or a Certificate of Pharmaceutical Product before they will register your product. In India these are issued by the State Licensing Authority following an inspection against WHO TRS guidance and Schedule M.
Do I need an FSSAI licence before importing, or can I apply per consignment?
Before importing. An FSSAI Central Licence must be held by the importer and must cover the product categories being brought in. Consignment-level clearance through the Food Import Clearance System is a separate step that assumes the licence is already in place.
How long does a drug stay classified as a new drug in India?
Four years from the date permission is granted. During that period the approval remains with the Central Licensing Authority, so a State Licensing Authority cannot independently grant a manufacturing licence for it. After four years it moves out of new drug status unless it is still under the definition on other grounds.
Timelines above are indicative. Statutory periods and fee schedules change, so treat this as orientation and confirm the current position for your specific product before you plan around it.
Tell us what you need to file
Send the product category and where you are in the process. You will get a written view of the pathway and what it will take, not a sales call.
Ghaziabad 201002, Uttar Pradesh