SCOPE OF SERVICES

➢ We Provide expertise and support in pharmaceutical Training, Auditing, and Consultancy.

➢ The details Scope of Services are mentioned Below.

We provide expertise and Support in the Scope of Service

Having more than 03 decades of combined experience in the Pharmaceuticals field of Operations, Manufacturing, GMP and Regulatory compliance, project handling, Training, Audit compliance, and Business Development

Training Support

  • On-job, cGMP, data integrity, GDP and updates on Regulatory guidelines
  • Skill development training, latest trends and requirements of pharmaceutical industries
  • Train the Trainer programme
  • Leadership development programmes (onsite and off-site)
  • Emotional intelligence at the workplace
  • How to face Audit and requirements during Regulatory audits
  • Yield improvement and cycle time Reduction in manufacturing
  • Executive presence and Team Building
  • Pharmacovigilance requirement by Health experts (By Expert Doctors)
  • Freshers development programmes and skill mapping Training.
  • Academic Training programmes for Pharma and Chemistry Graduates. (online and offline)

Audit & Compliance Support

  • Support in Plant regulatory and non-regulatory audits.
  • Gap analysis Audits
  • Regulatory Approvals
  • 483’s & Warning Letter response preparation & remediation.
  • Quality Systems GAP Assessment & Auditing.
  • Compliance plan for mitigation of data integrity risks.
  • Transforming Quality Management Systems through automation.
  • Preparation, upgradation and review of all the documents required. (including SOPS, formats, and annexures)
  • GMP GAP Assessment (as per USFDA, MHRA, EDQM, TGA, WHO, PIC/s, Schedule M and other regulatory requirements).
  • Third-party audits on behalf of clients in India and abroad.
  • Preparation of all types of Risk assessments and Data security compliance plans.
  • Developing & Implementing Quality Management Systems.
  • Compliance Audit assistance in adherence to cGMP / GLP compliance
  • Vendor Qualification and site vendor Audits and Support.

Qualification and Validation

  • Process Validation, Cleaning Validation, Analytical Method Validation, HVAC Validation, Water system Validation, Area Validation, Analyst Validation, Gowning Validation.
  • Equipment qualification (Preparation and review of V-Model approach)- From URS preparation to Qualification Summary (Equipment Release Note) report preparation
  • Computer System Validation support (Preparation, Review and Implementation)
  • New project design, development, machinery selection, procurement, qualifications and compliance.

Greenfield Projects Support

  • Designing, Planning and executing the Projects.
  • Consultancy for OE (Operational Excellence).
  • Layout & Drawings review
  • Preparation and review of process and plant layout, equipment layout etc.
  • HVAC, Water system and utilities-related document preparation and review
  • Equipment design, procurement & installations
  • Help you to reduce the operational cost & improve the cost saving by performing OE & GAP analysis.
  • Designing and ensuring sustainable and strategic cost reduction.
  • Sizing of equipment and allied detailed engineering including utility estimation.
  • Guiding Civil Work of the plant as per requirement of cGMP.
  • Guiding Installation of Central AC, Water system, and HVAC Systems.
  • Advising Installation of Laboratory Equipment as per GLP Guidelines.
  • Advising stability studies as per the ICH guidelines for all the products to establish their shelf life.
  • Maintaining of QMS / EMS.

Technology Transfer Support

  • Technology transfer and validation
  • Product launch
  • Dossier Submission
  • R&D trials and Pilot scale batch support
  • Stability studies and support for Third-party analysis of Samples
  • Training and documentation in all areas.

Upgradation of Existing Plant / Facility

  • Update existing documents to a GMP/Regulatory level.
  • Update the facility
  • Re qualifications/validations
  • Capacity calculations and Yield improvement projects
  • Cycle time reduction projects
  • Designing and ensuring sustainable and strategic cost reduction

Process Optimization

  • Preparation of Detailed Project Report, Pre-qualification study report, Site qualification study report and Pre-engineering study report.
  • Review of the Process and Material flow and subsequent civil modifications of the plant as per the requirement of cGMP.
  • PMC including review of the HVAC and Water System; and checking their validation to ensure the system and documentation are in order.
  • Advising Automation or conversion to cGMP model of plant and machinery as required.
  • Review and gradation Facility, Validations, Calibrations and Maintenance in totality.
  • Conducting study for BMS Compliance.
  • Facility Design and upgrade for compliance with all regulatory guidelines for both API and formulations.
  • Helping in Containment Plant setup.

We provide Expertise Support In

Having more than 03 decades of combined experience in the Pharmaceuticals field of Operations, Manufacturing, GMP and Regulatory compliance, project handling, Training, Audit compliance and Business Development.

Business Transformation

  • Consultancy for new Projects and Access to International markets.
  • Helping in the selection of products for International markets.
  • Distribution / Supply of Equipment Change Parts and Microbiology Laboratory Consumables (such as Ready to use Media)
  • Facility audits, Documentation, Dossier preparation& submission, Product Registrations and integrated product development.
  • Motivational talk to Corporate

Providing Consulting and Certifications

  • ISO 9001, 14001 and OHSAS18001consultancy.
  • Manpower support for different roles ( From Junior levels to Hiring support for higher positions
  • Internal auditor’s training and Certification

Dossiers filling and Quality Support

  • Dossiers Preparation, Review &Submission.
  • Documentation for Regulatory Compliance.
  • Product Registrations into various markets.
  • Compliance Audits. Compliance / Remediation to Audit Observations.
  • Quality Management systems compliance like change control, deviations, OOS, OOT, complaints, APQR, self-inspections, batch release, stereos control etc.