Technical and Remediation Consultation

We work with industry experts and provide solutions to the clients as per their needs either on- site or as per requirements. We have an expertise in offering remediation’s for FDA Warning letter sites, help support in 483 responses and in any regulatory correspondences

We provide online consultation over phone or email to the pharmaceutical companies.

We offer consultation for:

Quality & Complaince :

  • Response to 483
  • Response to Market complaints.
  • Preparing Investigation report.
  • Preparing SOPs ,protocols,Validation reports and Quality manuals.
  • Help in supplier audits and inspections

Regulatory Compliance :

  • ANDA filings
  • IND, CTA, DMF, NDA/MAA preparation and review and life-cycle management
  • Specialized submissions: Special Protocol Assessment, Fast Track Designation Request, Orphan Drug Designation, TPP, Written Request, 505(b)(2), biowaiver request, briefing documents
  • Interface with regulatory agencies
  • Regulatory submissions – INDs, IMPDs, QOS

Nonclinical PK/TK/ADME and Clinical Pharmacology

  • Preclinical and Clinical PK Analysis using WinNonlin and Reporting
  • Prestudy Audits and Monitoring of preclinical studies for Regulatory Toxicology Studies conducted in India (OECD and FDA GLP)
  • GLP Toxicokinetics – TK analysis and Reporting

Documentation

  • FDA – US INDs; pre-IND briefing packages, reports
  • EU CTAs; IMPDs, CTD
  • TPD – Canadian CTAs; QOS
  • Drugs Controller India – INDs, clinical trial application
  • QbD
  • PAT

Technical Compliance:

  • Investigation and Trouble shooting
  • Process Improvement
  • Lab Compliance

Project Management:

  • Design and Engineering assistance for new plant
  • Set up of new departments
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