Our Services
Consulting
Implementing a robust Quality Management System with a risk-based approach is key to your compliance and success. Whether you wish to build your QMS from scratch up upgrade the existing one, we offer expert support to achieve your objectives as well as independent audits of your processes.
Working with the right vendors is vital to ensure they perform to the quality standards you need them to maintain. We offer vendor qualification and re-qualification audits as well as support in developing risk-based vendor oversight plans.
Following fitting Standard Operating Procedures helps teams to comply with regulatory requirements, work effectively and efficiently. We offer SOP gap analysis and support in developing or revising your SOPs to meet required standards.
Quality Assurance & Quality Control
Acceptance of study results by the Regulatory Authorities is the prerequisite of your asset further development. Whether you plan to out-license your molecule or bring it to the market yourself, regulatory compliance is mandatory all along the way.
We offer
- Quality oversight visits to study sites,
- Site staff training in GCP and study management for investigators,
- In-house and site preparation for inspections,
- Study site audits,
- TMF audits,
- CRO audits,
- CAPA Plan development and implementation support.
Medical Writing
A clear, well-written, easy-to-read study protocol helps to get your studies approved without delays and study sites to conduct your studies with less deviations. For submissions to Regulatory Authorities, your Clinical Study Reports should be accurate, readable, with clear presentation of study results. And if you wish to publish the results, your manuscript must follow the Journal’s Guide for Authors and capture the audience. We offer medical writing expertise to save your time.
Training Courses & Workshops
As the drug / device development and clinical trial landscape keeps evolving, continuing professional development is a must to stay competitive. We offer numerous courses tailored to our clients’ needs. Courses on high demand include:
- Clinical Project Management
- Clinical Risk Management
- GCP for Study Sites
- GCP for Sponsor’s Clinical Operations teams
- Quality Management in Clinical Trials
