Sourcing OF API & FDF


Sourcing of API & FDF

- Procurement of best quality of Raw Materials, Packing Materials & Finished Goods at competitive price from established manufacturers /trading houses across the globe

- Contract Manufacturing: Help to find best quality CMOs worldwide. With a guarantee of GMP Compliance & Pharmexpert Reliability.



COMPUTERIZED SYSTEM VALIDATION (CSV)


System validation includes but not limited to;

ERP Systems/ DMS/ Network & PC based Systems/ Facility/ Utility Systems/ Barcode Systems / Warehouse Management Systems/ Building Automation Systems/ Computerized Maintenance Management Systems /PLC/DCS/SCADA/MES/EBRS/Automated Process Equipment

Clinical: eCRF, eSD, eTMF, Patient Database, IV/WRS…), Data Migration plan and Data Quality Control.

  • - Workforce support
  • - IT Infrastructure validation
  • - SOP on Computerized System Validation
  • - DATA Management System
  • - Validation Plan
  • - URS/SRS – User/System Requirement specification
  • - DCS - Design and Configuration specifications
  • - FRA - Functional Risk assessment
  • - IOQ test scripts - installation and Operational qualifications
  • - RTM - Requirement Traceability matrix
  • - All access rights and logical securities
  • - Execution and Approval- Computerized System Validation
  • - VSR validation summary report
  • - DIRA Audit: Assess risks to data integrity as your data flow through your systems as 21 CFR part 11/ EU annex 11.
  • - Spreadsheet (Excel sheet) Validation
Computerised System Validation


TRAINNINGS


Trainings

Learner Centric Approach

From basic GxP to advanced specific trainings



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Our Experienced subject matter experts provide correct training on all GXP topics, Policies, Procedures, Documentation, Data Integrity and Customized topics to enhance operational excellence and serve as best tool to mitigate risks at cost effective manner.

List of Trainings (Not limited to…)

- GMP/GDP Compliance and Topical Matters

- QMS implementation training

- Training on Onsite Audit/ Remote Audit

- Corrective action and preventive action

- Risk management system

- Process validation

- Cleaning validation

- Qualification

- Good Laboratory Practice (GLP)

- Safety & Personal hygiene

- Other classrooms/specific training



RESEARCH & DEVELOPMENT (R & D) SUPPORT


  • - Process development
  • - Lab validation
  • - Product mapping
  • - Process optimization
  • - Technology transfer for commercial scale
  • - Trouble shooting
  • - Controlled strategies of impurities
  • - Impurity profile and justification
  • - Impurity Structure elucidation report
R & D Support


PHARMACOVIGILANCE


Pharma covigilance
  • - ADR Reporting through Vigiflow
  • - Aggregate report writing / Medical and technical writing for PSURs (periodicsafety update report)
  • - Product Feasibility Reports for Medical Devices/Drugs
  • - Medical and technical writing for clinical study reports and annual reports
  • - Clinical Summaries.
  • - SAE Narratives for Clinical Study Reports
  • - RMP, SOP writing


BUSINESS SUPPORT


Assisting Clients strategically position & promote products & services into new markets, attract new customers, increase sales & ultimately increase profit.

Business Support


PROJECT MANAGEMENT


Project Management

We provide Comprehensive project management services with dedicated Project management team with Complete scheduling of project activities for time bound project delivery. Which includes; Site Identification, Project risk identification and management, Team identification, Audit and Selection through budget finalisation, Protocol Review, Complete coordination and Monitoring of Project from Start to end till Final Closure and report submission.



TEMPORARY STAFFING


  • - Do you need trained and capable staff members instead of a team of experts?
  • - Do you have gaps in project execution that can’t be economically filled by a consultant?
  • - Are you too busy to recruit, qualify and manage temporary workers?
  • - We offers qualified professionals for temporary or direct hire to support your internal needs.
  • - Our associates work on site and report directly to your staff. Whether you need someone with substantial or minimal experience, We have the resources to meet your project requirements.
  • - Of course, you can interview and approve every individual we provide. All staff associates are thoroughly qualified by the professionals. Our Staffing Services are perfect for companies that Need qualified personnel to supplement your validation, quality, laboratory or engineering teams, Have short term staffing needs to meet your project demands Are under a hiring freeze but still need qualified help.
  • - We help fill the gaps in your quality, laboratory, engineering and validation projects. We can support a wide range of areas.
    Please connect us for more details
Temporary Staffings

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