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
Related News
Related Resources
Related Services
- 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
- 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
Our project team were very impressed with the quality of the research and the reports that you sent through. We didn’t need any convincing that your recommendations should be followed. It showed PharmaLex in a very positive light, and the Project Team are keen to work with you again.
Head of Medical Writing and Publications
Highly competent, knowledgeable, absolutely reliable and dedicated to the projects
Senior Director