PRODUCT ACQUISITION
PRODUCT ACQUISITION
Aspects of the supply chain, lead time management, and follow-up for timely forward of shipments
Securing an appropriate product from the precise manufacturing unit at the justified cost
Capturing responsibility for every regulatory requirement
Regulatory affairs and record subsequent studies
Inspection and quality control
REGULATORY
Compilation and submission of dossiers Non-CTD to CTD, ACTD, eCTD, NeeS, Country Specific or Regional Submission for ASEAN, MENA, LATAM, EU, CIS, AFRICA, GCC, and many other row markets
Validation of Analytical Methods for Dissolution, Identification, Assay, Related Substances (Impurities), and Residual Solvent. Impurity Profile Validation (HPLC- with chromatogram, UV- with spectrum)
Clinical Trial Application in DCGI & BE NOC as per DCGI, INDIA's New Amendments
Dissolution profile comparison (HPLC with chromatogram, UV with spectrum)
ACTD dossier preparation / DMF-ASMF creation
BA/BE studies and clinical trials
TECH TRANSFER
TECH TRANSFER
Structure of governance and decision-making centralized
Systems for communication and documentation
Quality control and regulatory compliance
Risk management and gap analysis
Coding of process knowledge
Supply-chain administration
Structure of an organization
Project administration
DOSSIER
Compiling, submitting, writing, and auditing CTD dossiers (for markets in ASEAN, MENA, LATAM, EU, CIS, AFRICA, GCC, and numerous other regions). Dossier Conversion (non-CTD to CTD, CTD to pCTD, eCTD to pCTD, ACTD, eCTD, NeeS, Submission for a Country or Region) Clinical Trials (Clinical Trial Studies/Pre-Clinical Trial Studies through Reputable Study Centers; Clinical Trial Report Writing; Clinical Trial Application in DCGI & BE NOC As per New Amendments from DCGI, INDIA); Compliance with ASEAN, CIS, and Other Relevant Markets for Paper ACTD format & eACTD format writing & submission; ACTD dossier compilation, submission, writing, and auditing
OUTSOURCING MANUFACTURING
OUTSOURCING MANUFACTURING
A successful business's underlying principle is "we believe in connecting with people rather than simply communicating." The concept has been incorporated into Intsia Pharma's business strategy, which offers contract manufacturing for your brands and products. As a consequence, pharmaceutical companies can now launch their own brands and products rather than the need for their own manufacturing facilities