Services for Manufacturers
- Application for new drugs including Biological, Medical Devices/Clinical Trials/Global Clinical Trials/ new claims in consultation with New Drug Advisory Committee (NDAC)/Medical Devices Advisory Committee (MDAC)
- IND applications in consultation with IND committee
- Subsequent new drugs
- Clinical Trial Protocol Amendments (If consultation of NDAC is not required)
- Fixed Dose Combination in consultation with NDAC
- Import Registration of drugs and medical devices
- Endorsement of Additional Product in Registration Certificate
- Rule 37 and Neutral Code
- NOC for Form 29 (Biological and Medical Devices)
- CLAA in Form 28/28-D/28-E/27-C etc.
- Import License in Form 10
- Test License in Form 11
- Bioavailability/ Bioequivalence (BA/BE) study
- Extension of Shelf Life for export
- Export of Biological Samples
- Registration of Cosmetics
- Registration of Ethics Committee for CT
- Post-Approval Changes (major) in consultation with CDL, NDAC
- Post Approval Changes (minor)
- BA/BE Site Approval (after receipt of Joint Inspection Report)
- Written Confirmation as per EU Directives
Services for Importers
For importers, we provide the following services
Pre-Marketing Support
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Authorized agent/ registration holder support
We have a valid wholesale license and support our customers by acting as an Authorized Agent or Registration Holder. We help MNCs import and register their products -
Market Authorization
We help our clients all the way in the process of Market Authorization -
Import License
We assist our clients to get the import license smoothly quickly -
Test License
We help prepare the complete documentation for getting the test license in Form-29, Form-30
Post-Marketing Support
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Rule 37 Permission
We help customers import medicines for retail sale. -
Re-Registration
We assist our clients update documents for filing/re-registration with appropriate documents for obtaining renewals -
Self-life Extension
The regulatory team at S2M Life Science will help you acquire shelf-life extension for your products by filing the required documents with the regulatory authorities to facilitate quick permissions.
Global Regulatory Services:
- Compile, review, publish and file regulatory dossier
- Manage the submission of dossier
- Life cycle management and investigational filing
- Compile and publish reports
- Develop content and documentation
- Pre- and post-registration services
Pre-Registration services
Regulatory and quality compliance services and export report
- Conversion of data or document or dossier to country specific or ACT to CTD and vice versa and analysis of gap.
- Assessing the documents and existing dossier
- Site due diligence for Active Pharmaceutical Ingredients (API) site and Finished Product (FP) site and GMP compliance
- Assisting and providing guidance on adequate and relevant data generation for the submission of dossier successfully to country specific regulatory Authorities.
Post- Registration services
We provide post-approval regulatory changes to ourcustomers and assist themin addressing variations (major, minor or critical). We help updateexisting documents as per the country-specific regulatory requirements. We also provide assistance in the extension of labels and shelf-life.
Consultancy services for
