Overall Professional Services at Zonal and central CDSCO Level

PharmaSolve Technical Advisores LLP, We offer a wide range of professional services at the zonal level, focusing on regulatory compliance, quality management, and operational excellence for businesses. Our experienced team supports organizations in navigating regional regulations and optimizing their processes for enhanced performance.

• NOC for Form 29 & Dual Use
• WHO GMP Certification
• WC (Written Confirmation) Certification
• Additional product permission in WHO GMP/WC
• WC application
• NOC for Form 29 in CT form
• Export /R&D NOC for New drug
• NOC for grant of permissions for import of dual use items, not for medicinal use.
• Import test License of old products in (Form 11)
• Import Test License of New products in CT form
• NOC for Unapproved API
• NOC for Unapproved Formulation in CT form
• New/ Subsequent Drug Formulations
• New/ Subsequent Bulk Drug
• New/ subsequent fixed Dose Combinations (FDCs).
• Import Registration / Re- Registration (Form 41);
• Import License (Form 10).
• BE NOC for Export purpose.
• Export NOC of banned drugs.
• Shelf-Life Extension for Export Purpose.
• Registration of Ethics Committee.
• Approval of BA-BE Center.
• Approvals Notifications or No- objections for Protocol/ Protocol Amendments of Global
• Clinical Trial/ Domestic Clinical Trial.
• Embassy Attestation