Regulatory Services Coverage – Domestic Market (India)

“End-to-End Regulatory Solutions Across India.”

Sterovance Biotech, a division of Zoesoe Exports Private Limited, along with regulatory expertise from Pragya Dossier-DMF Services, provides comprehensive regulatory services across India’s pharmaceutical and healthcare sector.

We support manufacturers, marketers, exporters, and startups with end-to-end regulatory compliance solutions, ensuring smooth approvals, documentation, and market readiness as per Indian regulatory requirements.

Regulatory Authorities We Work With

We have extensive experience dealing with central and state regulatory bodies including:

• Central Drugs Standard Control Organization

• State FDA authorities across India (Gujarat, Maharashtra, Telangana, Tamil Nadu, etc.)

• Food Safety and Standards Authority of India

• Ministry of AYUSH

Our Domestic Regulatory Coverage Across India

We provide services across major pharmaceutical hubs:

• Ahmedabad

• Mumbai

• Hyderabad

• Baddi

• Pune

• Bangalore

• Chennai

• Kolkata

• Indore

• Vadodara

• Vapi

• Ankleshwar

• Visakhapatnam

• Delhi NCR

We ensure pan-India regulatory support, both onsite and remote.

Our Regulatory Services Portfolio (India)

1. Drug Regulatory Services

• New Drug Approval (Form 44 / NDCT Rules)

• Manufacturing License (Form 25 / 28)

• Loan License & Third-Party Manufacturing Approval

• Import License (Form 10 / 41)

• Test License (Form 29)

2. Dossier Preparation Services

• CTD / ACTD Dossier Preparation

• Module 1 to 5 Compilation

• Technical Document Writing

• DMF (Drug Master File) Preparation

• Gap Analysis & Deficiency Response

3. Nutraceutical & Food Regulatory (FSSAI)

• FSSAI Central/State License

• Product Approval & Label Compliance

• Nutraceutical Dossier Preparation

• Import Clearance Support

4. Cosmetics Regulatory Services

• Cosmetic Manufacturing License

• Import Registration (Form COS-1 / COS-2)

• Product Information File (PIF) Preparation

• Labeling & Compliance

5. AYUSH / Herbal Regulatory

• Ayurvedic / Herbal Product License

• Classical & Proprietary Medicine Approval

• Export Documentation Support

6. Clinical & Technical Services

• Bioequivalence Study Support

• Clinical Trial Documentation

• Analytical Method Validation (ICH Guidelines)

• Stability Study Protocol & Reports

7. Post-Approval & Compliance Services

• License Renewal & Retention

• Change Control (Site/Product/Process)

• Pharmacovigilance Support

• Audit & Inspection Readiness

Our Working Process (Domestic Regulatory Services)

1. Requirement Analysis
   Product category | Regulatory pathway

2. Documentation Review
   Gap analysis | Compliance check

3. Dossier Preparation
   CTD/DMF | Technical documentation

4. Submission
   CDSCO / State FDA / FSSAI / AYUSH

5. Query Handling
   Deficiency response | Follow-ups

6. Approval
   License / Registration grant

7. Post-Approval Support
   Compliance maintenance | Variations

Why Choose Us for Regulatory Services in India

• Strong expertise in CDSCO and state FDA regulations

• End-to-end regulatory and documentation support

• Experience across pharma, nutraceutical, cosmetic, and AYUSH sectors

• Fast turnaround with compliance accuracy

• Pan-India service coverage

• Professional dossier writing and submission support

• Trusted by manufacturers and exporters

Your Trusted Regulatory Partner in India

Sterovance Biotech and Pragya Dossier-DMF Services are committed to supporting the Indian pharmaceutical and healthcare industry with reliable, compliant, and efficient regulatory solutions.

Hashtags (Regulatory Services India)

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