Our Services
What We Do...
Contract Research Organisation Services
Our company provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis. We provide such services as biopharmaceutical development, biologic assay development, commercialisation, preclinical research, clinical research, clinical trials management, and pharmacovigilance.
We are designed to reduce costs for companies developing new medicines and drugs in niche markets. We aim to simplify the entry into drug markets, and simplify development.
We also support foundations, research institutions, and universities, in addition to governmental organisations (such as the NIH, EMA, etc.). We specifically provide clinical-study and clinical-trial support for drugs and/or medical devices.
We Offer
Innovative Solutions
Pharmacovigilance
Meeting clinical study or post-marketing pharmacovigilance (PV) obligations is a key requirement for your company. If you need resources or know-how, the SB Pharma team can offer personalised services either to strengthen your own PV functions or as a full-service PV solution.
Medical Device
SB Pharma brings a new level of customer attention, flexibility and reliability from early regulatory consulting all the way to medical device trials and CE-mark and 510(k) submissions. With Regulatory Strategy & Intelligence. Clinical Operations and Submission Management
Operations
Our team is experienced in providing service in all phases of clinical development for pharmaceutical, medical device and oncology trials. We provide a full-service concept offering the entire study team for all functions, or professionals working as a part of the customers’ study team.
Data Services
Our team has expanded its own services offering to include Data Management and Biostatistics, with its newly implemented Data Services Function. A vital part of the clinical trials life cycle, Data services has the capability to operate on a Global level for trials of any size.
Quality Assurance
Our Quality Assurance Services can support you to develop, implement and update your quality systems and procedures to conform to current guidelines and regulations. We also provide auditing services to help you identify your strengths, as well as areas that need improvement.
Medical Language Services
If you need high quality translations for your clinical trials, drug regulatory affairs or pharmaceutical marketing. Our Medical Translations team provide commitment and complete focus on client specifications. Our qualified project managers work efficiently to process your files and projects.
Chromatography Tests…
Our chromatography laboratory offer analysis, quantifying, identifying substances and compounds. Providing routine advanced analytical testing, with detection levels down to ultra trace-levels. A diverse array of materials and products can be tested by our chromatographic techniques.
CRO Study Service
We support pharma and biotech companies with study operations to put the study back on track and bring it to a successful conclusion. Giving a fresh point of view, new ideas or just simple support. We can provide assistance in: study documentation, monitoring from start-up to close-out, recruitment, quality and timelines.
Regulatory Affairs
Our main services cover clinical trial application submissions, regulatory strategies and documentation as well as regulatory procedures for pharmaceuticals and medical devices. The application process can be a full-service project, or we can provide support in any individual part.
