At S-Cube Regulatory Services , we provide comprehensive regulatory consulting solutions for the pharmaceutical, medical device, cosmetic, nutraceutical, herbal, and biotechnology industries.
Our Services includes following:
1) Regulatory Affairs Consulting
- Strategic regulatory planning and compliance solutions tailored to your business
objectives.
2) Product Registration
- Preparation and submission of regulatory applications for pharmaceuticals,
medical devices, cosmetics, and nutraceutical products.
3) Dossier Preparation
Preparation of:
- CTD
- ACTD
- eCTD
- Technical Files
- Product Information Files
- Quality Documentation
4) CDSCO Services
Import License
- Manufacturing License
- Product Registration
- Test License
- Clinical Trial Support
- Regulatory Compliance
5) Medical Device Regulatory Services
- Device Classification
- Technical Documentation
- Registration Support
- Import License
- Manufacturing Compliance
6) Cosmetic Regulatory Services
- Cosmetic Product Registration
- Ingredient Review
- Label Compliance
- Import Documentation
7) Nutraceutical Regulatory Services
Regulatory guidance for food supplements, nutraceuticals, and wellness products.
8) GMP Compliance
- SOP Development
- Documentation
- Internal Audits
- Gap Analysis
- Training Support
9) Pharmacovigilance
Drug safety reporting and regulatory compliance services throughout the product
lifecycle.