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Our Services

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Our Services

We provide a full range of regulatory services to support your business growth

1. Dossier Development & Submission

CTD (Common Technical Document)
ACTD (ASEAN CTD)
eCTD (Electronic CTD)
NeeS Format
Country-Specific Dossiers

2. Product Registration

Market Authorization Applications
New Drug Application (NDA)
Site Registration
Cosmetic, Food Product & Herbal Approvals
Import/Export Registration
Variation Approval

3. CDSCO (India FDA) Services

Drug & API Import Registration (Form 43)
Site Registration
FSSAI Licensing
Cosmetic Form 44 Registration
Medical Device Approval
Test License (Form 12)

4. Clinical & BE Studies Support

Protocol design and documentation
Bioavailability / Bioequivalence Studies
Clinical Trial Document Compilation
PSUR (Periodic Safety Update Reports)

5. Pharmacovigilance Services

ICSR Case Management
Aggregate Report (PSUR, PADER, DSUR)
Risk Management Plan (RMP)
Literature Search and Signal Detection
Inspection and Audit Support

6. Technology Transfer

Identification of suitable partners
Product evaluation and technical support
Contract negotiations and documentation
Formulation transfer support

7. Contract Manufacturing

Sourcing of Finished Dosage Forms & APIs
Ready-to-fill pellets
Plant with WHO-GMP/TGA/MHRA approval

8. In-licensing & Out-licensing

Global partner search and negotiation
Licensing support for APIs, formulations, devices
Market entry support and pre-launch guidance

9. Medical Devices Regulatory Support

Technical File/Design Dossier Preparation
CE Marking Assistance
Regulatory Gap Analysis
Medical Device Vigilance

10. Artwork/LBL/Promotional Designing

End-to-end packaging design support from concept to production
Expertise in pharmaceutical and medical device packaging
Regulatory-compliant and market-oriented artwork
Print-ready files for all packaging types
Creative, customized, and eye-catching design solutions
Precision-driven artwork origination

Have Any Query? Feel Free To Contact Us

Contact Number:

+91 94272 89712

Email:

elvinpharmconsultant@gmail.com
info@elvinpharmaconsultant.com

Address:

J/402, Maruti Heritage-2, Saijpur Bogha, Krishna Nagar
Ahmedabad – 382345, Gujarat, India