Step-In Pharma SRL has qualified expertise in:
- Consultation and project management for Implementation/Upgrading of Quality Systems
- Helping companies with ongoing QMS compliance
- Quality Assurance (QA) Outsourcing
- Assistance to supplement your company in-house
- Expertise, allowing you to overcome staffing shortages
- Provide training or obtain independent
- Auditor assistance.
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- Regulatory Affairs
- Pharmacovigilance
- Clinical trials
- GxP/Other Quality systems (ISO 9001, ISO 18001, ISO 13485, others)
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Step-In Pharma SRL ensures:
- A thorough analysis of your service/business for the system certification processes ISO
- Project assessment customized to your requirements
- Innovative approach to the processes
- Highly cost-effective projects customized to meet legilslative requirements
- Totally professional approach with on time completion of projects
- Invaluable advice in resolving quality issues of your company as per the related management systems
Step-In Pharma SRL perform various types audits:
- Routine audits (regulatory, pharmacovigilance, clinical),
- Cause audits,
- Inspection/Certification readiness audits for regulatory/certification body inspections,
- Vendor qualification audits,
- Audits of contractor facilities for supplier selection or GMP/GDP, GxP compliance (deal with the complex process of contractor selection and ensure you have the right expertise for each stage of the project).
- System Audits, Compliance Audit, Process Audit, Product Audit, Department Audit
- Quality Systems audits, clinical sites audits, database audits
- Warehouse audits
Step-In Pharma SRL staff are trained to audit against GMP/GDP, GCP, PV, ISO (9001 etc.)
Step-In Pharma SRL perform:
- First party quality audits (Internal audit - as external consultant)
- Step-In Pharma SRL can run independent audits to ascertain the level of compliance of your Quality Management System with applicable requirements
- Second party quality audits of the suppliers – as outside agency hired by the purchasing organization
- Step-In Pharma SRL offers full audit programm design and mangement for you, to address a specific need: supplier selection, carry out project-related compliance audits, and following-up with contractor to ensure continuous improvement.
- Preparatory audits before ISO Certification (including one-off audits), and before inspections of regulatory body
Step-In Pharma SRL
- Explain what inspectors require and ensure you have acceptable systems in place for both commercial supply of pharmaceutical products/medical devices and for clinical trials
- Work with in-house QA experts to improve presentation of facility and systems for Inspector
- Evaluate the risk to quality based on scientific knowledge and ultimately link to the protection of the patient (ICHQ9)
- Prepare response documents or appeals on your behalf
- Assist you in prepare robust CAPA Plan (Corective Actions/Preventive Actions)
For all type of preparatory audits Step-In Pharma SRL
- Review of processes and data including, but not limited to:
- Complaint handling system to ensure a functioning process exists for regulatory reporting to government agencies.
- Past inspection reports
- Corrective And Preventive Actions (CAPA) process to analyze the "time to closure" of complaints/incidents and verify
if complaint trends are correctly entered into the CAPA system and addressed accordingly.
- Management review meeting minutes to determine level of management involvement in quality and regulatory compliance.
- Document control and maintenance of the quality system
- Review of facilities and quality management systems
- Offers trainings on your staff on internal auditor, risk management, quality system, or other training needs.
- Assess potential pitfalls and help you avoid them.
Step-In Pharma SRL help you to:
- take the fear out of the regulatory/certification inspection process
- ensure your procedures meet current standards
- achieve the best outcome to any regulatory/certification inspection
Step-In Pharma SRL designs Quality management for your business:
- assessing the needs of your company and create a quality management system that suits your operation.
- assisting you in meeting compliance with GMP, GDP, GCP, GVP, ISO 9001, ISO 18001 and other best-practice/s quality systems.
Each business differs from another and therefore requires customized and effective quality systems.
Certification consultancy
Apart from quality management services, Step-In Pharma SRL also extend our in consultancy service for preparing you for a large range of system certification.
Certification advantages:
- Certification can lead to increased efficiency, better product quality and improved customer service within your company.
- Having a globally recognized standard and the certification will increase the credibility of your company with potential customers.
- Demonstrate to your consumers and partners a commitment to quality
Step-In Pharma SRL
- Guarantee you will pass your first certification audit if you follow our plan.
- Review of QMS to evaluate current status and likelihood of maintaining existing certification
Quality Assurance (QA) Temporary / Long Term Outsourcing
Step-In Pharma SRL can offer you full or "as needed" consulting for ISO and/or GxP quality assurance by enssuring:
- flexibility to respond to issues quickly
- maintenance of regulatory/quality compliance
- continuous improvements to your quality management system to operate more efficientlys
- you can concentrate on your core business objectives
Many small or large pharma companies are choosing to outsource some of their quality assurance tasks as a way to ensure compliance in the actual changing and increasingly complex regulatory environment.
Smaller companies
- quality assurance tasks are often added to the responsibilities of personnel who do not have the knowledge or
experience to handle them.
- As a result, regulatory compliance and ongoing quality system improvements may not receive the attention
they require. This can lead to potentially negative and costly consequences such as lost customers, non-compliant
suppliers or serious challenges from Competent Authorities.
Larger companies
Even having established QA departments, supplement of their in-house expertise, by overcoming staffing shortages, provide training or obtain independent auditor assistance.
Technical Assistance for Ready-to-use Documents
- Do you need technical assistance in preparing a Quality Manual, Site Master File, Pharmacovigilance Master File?
- Do you need qualified assistance in revising/upgrading your internal processes/procedures (Standard Operating Procedures)?
Step-In Pharma SRL provides
- ready to use customized documents, aligned with your processes and applicable legislative requirements
- additionally, on-request, presentation kits/trainings to facilitate fast implementation and follow-up by your company staff
The number and variability of projects typewe are dealing with, bring continuosly broader and higher qualified expertise!!
If you are a new pharmaceutical company or an established business wanting to expand, please contact Step-In Pharma SRL
We use our experience to advice you, to provide end to end solutions of your project needs and help you to get projects completion with required results and within defined budgets and timelines.
Quality systems are not just an expense! Quality system is an investment for improving business!
