Services
BS has highly educated pharmaceutical professionals with international M.Sc. and Ph.D. degrees and experience from multinational pharmaceutical companies (EU and US FDA approved), three of them are also former EU Inspectors (GMP/GDP/GCP/GLP/GVP). All employees were also exposed to successful US FDA inspections and former inspectors were trained by US FDA as a part of US FDA and EU MRA project. Croatian Inspectorate led by our COO was among first 8 EU member states to be recognised by US FDA as equal after thoroughly evaluated by US FDA which included observation of work of our former inspectors. IBS employees are active in different scientific, regulatory, and academic working groups, also acting as trainers and speakers on conferences and webinars organised for professionals in industry, regulatory institutions and academia.
QP Services
• Permanent & Temporary QP Cover
• Product Release
• Quality System Review & Implementation
• Risk Management
• Supplier Assessment Review & Management
Quality Management System
• Quality Manual Development & Upkeep
• Site Master Files
• Test Methods
• Technology Transfer
• Product Recall Procedures
Training
• Supplier Assessment Programmes
• EU Supplier Assessment Requirements
• Auditor Training
• Risk Management Systems and Procedures
• GMP & GDMP
API Sourcing
• Advice on the selection of GMP Compliant API manufacturers worldwide
• Assistance in developing business with API manufacturers worldwide
• Suppler Evaluation
Project Management
• GMP Project Assessment
• Gap Analysis
• Project Design & Implementation
• Change Management
• Scale up
Auditing
• ICH Q7 API Audits
• Finished Product site Audits
• Pre-inspection Approval Assessments
• GMP Gap Analysis
• Due Diligence
Regulatory AFFAIRS
- Regulatory strategy advice and execution
- Regulatory submissions under DCP/MRP¹ and pure NP²
- Post-marketing applications and MA³ maintenance support
- Linguistic support for product information of CAPs⁴
- Regulatory intelligence
- Regulatory documentation assessment and upgrade
- Compilation of quality, non-clinical and clinical overviews and summaries
- Readability testing of package leaflets
- Consultancy on promo and educational materials
Pharmacovigilance
- Appointment of local contact person for pharmacovigilance and deputy officer (24/7 service)
- Weekly literature screening and translation services
- Weekly monitoring of governmental websites, regulatory, and legal intelligence
- Communication point for the NCA¹, local HCPs², patients, client’s sales force and QPPV³
- Follow up of Individual Case Safety Reports
- Pharmacovigilance trainings of client’s sales force
- Support with DHPC⁴ and aRMM⁵
Market Access
- Acting as a local representative to national pricing and reimbursement bodies
- Conducting tailored market research and comprehensive competitive analysis
- Building market access strategies
- Pricing and reimbursement maintenance procedures
Why People Trust Us
The IBS services are underpinned by the highest quality standards, attention to detail and close relationships with clients so that project objectives are met efficiently and cost effectively. The highest ethical and confidentiality standards are maintained at all times.
High Quality Service
Connecting the industry with regulatory authorities is what we do.
Unmatched Expertise
We invest to find, engage, and grow the best talents.
Precise Result
The IBS services are underpinned by the highest quality standards, attention to detail and close relationships with clients.
Qualified Staff
We take it personally. You have a single point of contact.
Get One Step Ahead with our experience
IBS trained auditors are all specialists in the Pharmaceutical industry and have extensive operational experience in either manufacturing or quality management. Many of the auditors are QPs.
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