Confidence Beyond Compliance
Ensuring your internal systems, or those of your supplier or client meet the necessary requirements, is essential before undertaking any regulatory process. It is also pertinent to follow good practice (GxP) guidelines in order to satisfy the regulators that all aspects meet their standards.
A functional pharmaceutical quality system is not only a regulatory requirement, but also an integral element in pharmaceutical organizations to assure products’ pharmaceutical quality and patients’ safety. A well designed and efficient quality system will serve as a safe and sound basis for your business. It documents and verifies your approach for high quality products towards health agencies.
We have a broad spectrum of competencies in GxP quality management as well as in adjoining regulatory areas. This approach allows us to manage interfaces even in complex situations and provide additional value especially for small- and medium-sized organizations.
We offer advice, guidance and solutions in the following areas:
- Providing consultancy, gap analyses and operative support on GxP topics
- Designing, implementing and optimizing your GxP quality system
Preparing applications for manufacturing and wholesaling authorizations - Designing and documenting processes as SOPs
- Implementing risk management approaches / FMEA analyses
- Planning and performing GxP audits and self-inspections
(incl. CAPA management) - Preparing and supporting health agency inspections
- Supporting remediation activities
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- Biopharmaceuticals
- CMC Services
- Computer System Validation (CSV)
- Custom Software Development
- Digital Health Teaser Tool
- Global End-to-End Outsourcing
- Global Procedure Management
- Health Authority / Agency Interaction
- INTEGRATED PRODUCT DEVELOPMENT (IPD)
- Interim / Contract QA
- Lab Tools
- Literature Monitoring & Screening
- MedTech Services
- Mergers and Acquisitions (M&A) Transfers
- PAI Readiness
- Pharmacovigilance Systems
- Quality Management Systems
- Regulatory Operations
- SMART MDR Teaser Tool
- SMARTAUTOMATE
- SMARTCHECK
- SMARTCHECK MDR
- SMARTCHECK-MDR
- SMARTDECISIONS
- SMARTENOVAL – analytical method validation software
- SMARTPHLEX
- SMARTRISK
- SMARTSEELVA – bioassay validation software
- SMARTSTABELITY – product stability and shelf-life estimation software
- SMARTSTATS – statistical report writing
- SMARTTRACE
- SMARTTRANSVAL – analytical method transfer software
- SMARTVIGICONTRACT
- SMARTVIGILIT
- SMARTVIGISCREEN
- Statistics and Data Sciences
- Tech Transfer / Scale-up
- Technology Enabled Services
- Toxicology Services
- Virtual Audits
What our clients say
I just wanted to let you know that the recent EU Codes webinar was excellent. Rina presented a very complex and grey topic in the most clear and digestible manner – a sign of a true expert. The questions in the Q&A were sometimes a little ambiguous but Rina gave clear and relevant answers that provided real clarity.
Medical Team Leader, Multi Tumor Franchise Roche Products Ltd
During the bid defense we felt that you worked well as team and are very dynamic. Preparation of such a complex dossier really needs to be done in such a way.
VP Regulatory Affairs