Services

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US FDA Regulatory:-

• Abbreviated New Drug Application (ANDA) Submissions
• Drug Master File (DMF) Submissions as per GDUFA guidelines
• NDA 505 b (1) and 505 b (2)
• Investigational New Drug(IND) Applications
• Self Identification, Establishment registration, Product listing 

Health Canada Regulatory:-

• Abbreviated New Drug Submission (ANDS)
• New Drug Submission (NDS) for Canada
• Drug Master File (DMF) Submissions

European Drug Quality Management System (EDQM):-

• Active Substance Master File (ASMF) Submissions
• EU Marketing Authorization Application (MAA)
• Certification of Suitability (CEP) Submissions
• Decentralized Procedure(DCP)
• Mutual Recognition Procedure(MRP)
• National Procedure (NP)
• Centralised Procedure

•  Compliance and Audit 
•  GxP Audit Services
•  SOP Writing and SOP Review Services 
•  End-to-End Compliance Services
• Remote and Virtual Audit 
• Support to Pharmaceutical manufacturing companies to prepare compliance report with appropriate CAPA (Corrective and preventive actions certificate) to get GMP Certificates from the Indian and International FDA regulatory agencies

Dossier Preparation and compilation of CTD, ACTD, Nees, e CTD Format, DMF, CEP, ASMF, IND, ANDA, BLA, MAA & Medical Devices for any Dosage Form and Application type.

eCTD Conversion and publishing.

Communication with FDA Supporting companies for scheduling facility inspections of Bulk Drug (Active Pharmaceutical Ingredients i.e. Drug substance and Pharmaceuticals formulation i.e. Drug product manufacturing facilities, DMF query/responses communications.

Electronic Submission Gateway Setup for US, Health Canada, and European countries, Duns and Breath (DUNS), Facility identify the number (FEI), NDC code, Annual Establishment registration etc.

SOPs, Database, literature, Drug Safety/ICSRs, Clinical summary to Heath authorities.

All international translating Drug Master files and other Pharmaceuticals Documents.

• Regulatory Submission Strategy
• Dossier for the U.S. and the EU Regulatory Submissions
•  Compliance by improving Gap Analysis
• Post Approval Changes Submissions
• Lifecycle Management of product dossie