SERVICES

Overview

Indian Pharmaceutical Industry has made great strides as one of the largest exporters of generics in the world. The Indian Pharmaceutical industry now faces the challenges of unpredictable product pipelines, increasingly competitive markets, and uncertain policy and regulatory environments.

In its 10th Year of operation, DSSPL helps pharmaceutical manufacturers to become more competitive and successful in today's evolving market ensuring their products and processes meet the stringent regulatory scrutiny and increasing price pressures to navigate complicated and changing regulatory environment.

DSSPL offers competitive Customised Solutions in the area of Quality, GMP Compliance, EHS and Document Management throughout lifecycle of Products.

Compliance

  • Regulatory compliance
  • GMP compliance
  • Quality compliance
  • GLP compliance

  Audits

  • Data Integrity gap analysis and remediation
  • Vendor qualification  
  • Third-party GMP Compliance Auditing
  • Mock FDA/International Regulatory Agency Inspections
  • Formulations and API audits
  • Mock Inspections
  • Support post Regulatory Inspection
  • Environment Health and Safety (EHS)audits

Training

  • Quality
  • GMP
  • EHS
  • Business skills  
  • Mentoring and Coaching
  • Laboratory  

Documentation

  • DMF for bulk drugs
  • Dossier gap analysis and review for formulations and bulk drugs
  • CTD dossiers preparation and maintenance for Regulated and Rest of the world
  • Documentation review and remediation 
  • Annual Product Review
  • Data trending
  • Report writing

 Regulatory

  • Regulatory strategy for New drug application    
  • Regulatory support for clinical trial application   

Quality

  • QA/Quality Control Staff rationalization
  • Policy, SOP & MFR,BPR Review, Preparation & Optimization
  • Quality System (QS) Development, Assessment & Optimization
  • Root Cause Investigations & Corrective & Preventive Action (CAPA) Planning & Execution

Panel of experts lead by Dr Premnath Shenoy.

 

Types of Services

» Regulatory Services

» Support Services