About Us

We are one of the leading Regulatory and Quality Management Service Providers and Consultants of India. Our core activity is preparation of DMF/Dossiers/CTD/COS/SOPs/BPCRs and all GMP documents. We provide Comprehensive Solution for Preparation, Filing and Registration & Updates of Drug Master Files (DMF) for API & Registration Dossiers for Formulations at a single contact point. We also take–up the complete Project for the Qualification and Validation of Facilities/Equipments/Utilities and also for the preparation of CTD DMF for API or Dossier for Formulations. We can also help you to perform the Analytical Studies, Validation, & Spectral Studies for Active Ingredients (APIs) and Formulations. Our Panel of Experts is having rich experience in setting up systems like GMP as per WHO / USFDA / MHRA / MCC/PMDA/MHLW / ICH guidelines as well GCP / GLP compliance as per ICH Guidelines. We also undertake total turnkey basis project for GMP Compliance, starting from Plant Design to GMP Approval by any regulatory agency worldwide. We also impart Onsite GMP Training and also perform on site Process or Method Validation Studies. We are also dealing the procurement & supply of Reference Standards & Impurity Standards. We assure you, working with us will surely save your Time, Money & you will get pinpoint solutions for all your Regulatory and Quality Management Needs. We request you to visit us for a brief meeting to explore Synergies and Long Term Business Relationship to:

  1. Implement QMS based on FDA Quality System Regulations, WHO,EU and ICH guidelines
  2. Identify general compliance expectations of the FDA, EU,PMDA,ASEAN and local authorities for drug manufacturers
  3. Identify the key points of the Quality System Regulation
  4. Complete an initial “gap analysis” of what’s new/different in a regulated industry
  5. Identify the technical and non-technical requirements for organizational readiness for effective QMS implementation
  6. Identify a problem in standard interpretation; be able to resolve it to meet compliance
  7. Identify factors to consider when planning a QMS implementation: organizational environment, human elements, business objectives, and costs
  8. Identify cost saving and business value of registration to a QMS standard for the organization
  9. Identify role of important quality and productivity methods
  10. Identify tools that can assist and improve QMS implementation
  11. Identify EU/FDA/PMDA/ASEAN audit process and compliance issues

The service also provides correlation between different standards, applicable clauses and gap analysis. The quality management system service will establishes policies and requirements that apply to organizations employees, facilities, products and services involved in the design, manufacture, test, distribution, installation and servicing of products intended for use. The quality management system designed will ensure that products are safe and effective and to prevent non-conformance at all product stages from design through servicing.