CDSCO

Pan India Regulatory follow up for Approval.

• 1.CDSCO , FDA Bhawan , New Delhi
• • a. All Products Approval ( New , S&D, Regular)
  • b. Medical Devices
  • c. Import and Export NOC
  • d. Cosmetics / Nutraceuticals
  • e. Herbal / Ayurvedic
• 2. All State Drug Controls in India
• 3. All Central Drugs Laboratories in India eg Mumbai, Kolkata , Kasauli, Hyderabad etc
• 4. All Ministerial Offices at Central and States
• 5. IPC , Gaziabad
• 6. NIB , Noida
• 7. NIV , Pune
• 8. CDTL Lucknow
• 9. Department of Biotechnology ( DBT)
• 10. Indian Council for Medical Research ( ICMR)
• 11. AIIMS
• 12. DSIR
• 13. DST
• 14. TDB
• 15. All Embassies in New Delhi
• 16. Ministry of Commerce and Industry
• 17. Ministry of Agriculture

Effective Dossier Management

• 1. Compilation of Dossier as per Guidance for Industry
• 2. Registration in Sugam ( CDSCO online filing of application)
• 3. E-Filing follow up
• 4. Pre –Clinical and Clinical Protocol Development
• 5. Clinical Trial Management
• 6. Pharmacological Follow up and Guidance
• 7. Adaptation of CTD Formats for New Markets
• 8. Dossier Review and Gap Analysis
• 9. Strategic Regulatory Approval Planning
• 10. Authoring of Written Summaries and Overviews
• 11. Review and Advice on CMC, Nonclinical and Clinical Dossiers
• 12. SEC presentation Guide and preparation
• 13. Expert Review of Documents for filing and presentation
• 14. Labeling Updates
• 15. Preparation of Investigator Brochures
• 16. Phases I, II, III and IV Regulatory Support
• 17. Safety Reporting

Chemicals and other industry related regulatory follow up

• 1. Filing for Controlled Substance eg Acetic Anhydride , Sulfur ,Ammonia etc
• 2. Filing and follow up for Coal, Alcohol , Methanol
• 3. Information on Government regulatory Policy on SINGLE WINDOW

Pre-Screening Audits and GAP Analysis by the Experts

• 1. WHO-GMP
• 2. GMP
• 3. GLP
• 4. GCP

Collaborative Marketing Services

• 1. Registration of Products-Import and Export
• 2. API , FDC
• 3. Cosmetics
• 4. Biological ( r –DNA, Vaccine , Bio-therapeutics )
• 5. Nutraceuticals , Ayurvedic
• 6. Medical Device

Pilot Plant Scale up

• 1. Scope
• 2. Consultancy
• 3. Liaison

Technology Funding and Investment Opportunity

1. Engineering , Procurement and implementation

IPR and Trademark Filing and Consultancy

Utility

• 1. Boiler Installation / O &M
• 2. IBR Inspection

Land Bank for setting up industrial units

• Issues on Land allotment /
• Approval process in APIIC / TSIIC/ Commissioner of Industry / CCLA in Andhrapradesh and Telangana

Environment Management ( Pollution Control )

• 1. EC/ CFE / CFO Consultancy
• 2. Development of Natural Greenbelt as per PCB norms
• 3. Installation of Captive Solar Plant (Pilot & MW Scale )

Warehouse Solutions

Fire Safety management

1. Filing for NOC and Consultancy