Services
We help our clients with Human Resources Solutions, Ingredient Sourcing, Regulatory Affairs, Supply Chain Optimization, Supply Safeguarding & Quality ManagementHuman Resources Solutions
We offer headhunting and interim-management solutions for pharma and related sectors. Long lasting experience and expertise are key in assuring a successful placement with an effective onset in a highly regulated envirnoment such as pharma, biotech and related sectors. Our global industry network is a major asset helping you to find the right person for your needs.
Services
Ingredient Sourcing
Assuring the right ingredients for new R&D and life cycle management projects is a critical success factor. On-time availability, adequate GMP level, the right Regulatory Affairs support, suitable infrastructure and capabilities of the supplier are only a few of the aspects needed here. We have long lasting experience and an extensive network at the global component suppliers helping you with the sourcing of critical components for your projects.
Services
Regulatory Affairs
The right RA strategy is key to ensure product availability in the market and to guarantee reliable and fast approval timelines. This equally applies for new filings, life cycle management and changes. We have long lasting expertise helping you here. To name a few, we support you with authority-interactions, CMC services, dossier compilation, labeling, RA services for biologicals, medicinal products & small molecules and RA strategy in general.
Services
Supply Chain Optimization
A smooth supply chain is key for delivering life-saving products in time to the patient. Another aspect is the wise use of working capital by having lean and well designed supply chain processes. To name a few examples, we have profound expertise in implementing KPIs such as “On Time in Full (OTIF)“, conducting supply risk mappings, implementing capacity assessment tools and performing cost reduction programs for direct-spend material.
Services
Supply Safeguarding
Avoiding supply bottlenecks of finished dosage forms and ingredients is a top priority to provide patients with critical medication. Guidance Pharm has developed product classification models ensuring that no important item runs out of supply. We have developed a series of mitigation measures, which in combination with good contacts at the global manufacturers successfully prevent supply shortages.
Services
Quality Management
A well designed quality management system ensures patient safety and smooth processes throughout your organization. Among others, we have expertise in establishing and maintaining quality management systems, audit preparation and CAPA-plan implementations just to name a few quality services we offer.