- Providing services to Pharmaceuticals, Life sciences, Medical devices, Nutraceuticals, Health care and Cosmetic industries.
- GxP Audits, Third Party Audits, CMO Audits, CRO Audits, Regulatory Support Audits, External Quality Audits & Safety Audits.
- Providing of Internal, external GxP, Technical, Safety, & On-Job trainings.
- Supporting of anytime readiness for Regulatory Audits.
- All Pharma contract services (Validations, Qualifications, Investigations, QA, QC, RA, R&D, AR&D, Engineering, Stores & Green field projects...etc).
- Implementation of cGMP, GCP, GEP, GDP, QMS systems…etc.
- Conducting of quality risk assessment, Gap Assessment and Impact assessments.
- Supporting to inspections and closing of inspectional observations from USFDA, PMDA, EDQM, MFDS, ANVISA, COFEPRIS, WHO(Geneva), Reach, NMPA, MHRA, ISO (9001-2015), INFARMED, Health Canada, TGA CDSCO …etc
- All regulatory filings US, EU, JP, Canada, UK, India & ROW markets.
- SOPs, Protocols & Documentation preparations, to meet regulatory requirement.
- Cost saving / Cost reduction / Cost effectiveness & Decreasing of heavy documentation.
- Problem solving and Preventive actions.
- Investigation of OOS, Customer complaints, Deviations, OOT, Data Integrity incidents, OOE, & Lab incidents…etc.
- To prepare skilled employees and healthy competitors at pharmaceuticals.
- Implementation of comprehensive CAPA with proper justifications and evidences.
- Closing of day-to-day Challenges in industries
- Conducting training to Pharma aspirants/freshers.
- Contract lab services.
- Arranging Conferences & Debates on Pharmaceutical GMP and Technical updates.
- Providing of Skilled contract employees, Regular Employees & Part time employees for Pharma Companies.