Integrated support for development and registration
We support products for human and animal health, from early assessment and studies to registration and post-registration activities.
A complete project or an individual task, shaped around your needs.
Five areas of expertise
Start with your product category. We will define the route, scope of work and deliverables.
Medicinal products
From molecule assessment and development planning to registration, pharmacovigilance and variations.
Medical devices
Classification, testing, clinical evidence, registration and lifecycle support, including IVDs and software with AI.
Food supplements and cosmetics
Composition assessment, documentation, studies and regulatory procedures. Substantiation of product claims.
Veterinary products
Medicines, vaccines, feeds and additives, diagnostics, animal care products and other categories.
Statandocs software
PharmaDocker and proprietary solutions for regulatory work, research, evidence reviews and quality management.
At each stage
We can start at the beginning or join a defined task. Scope and responsibilities are agreed in advance.
A written assessment and route
We review the product, available data, options and risks, identify evidence gaps and plan the sequence of work.
- Positioning and classification
- Gap analysis and alternatives
- Study programme and project plan
Data, analysis and reports
We develop programmes and documents, select facilities and organise and oversee studies, with data management and biostatistics support.
- Nonclinical and clinical studies
- Real-world research
- Scientific documents and publications
A dossier and managed procedure
We prepare documents and assemble the submission. The client can file it, or we can manage filing, authority interaction and responses.
- Regional adaptation
- Dossiers, XML and sequences
- Regulatory procedures
Ongoing product support
We support safety, variations and further product needs, with an agreed scope and clear responsibilities.
- Pharmacovigilance and clinical monitoring
- Dossier and manufacturing changes
- Prices, product lists and further studies
Research, documentation and expertise
Capabilities that can be combined within a project or commissioned separately.
Clinical trials
Full-service CRO support, from the development programme and protocol to database lock and the final report.
Real-world research
Primary and existing data, a range of study designs, causal analysis and publications.
Biostatistics and data management
Study design, sample size, data management, statistical analysis, PK and PD.
Medical and scientific writing
Study and dossier documents, publications, systematic reviews and meta-analyses.
Pharmacovigilance
During trials, registration and after approval. Full outsourcing or selected activities.
Quality systems and inspections
Manufacturing assessment, quality systems, audits, inspection preparation and support.
Our own tools for your work
PharmaDocker brings together regulatory services and access to standalone Statandocs products. We implement and support our solutions ourselves.
SoftwareOne team for a complex project
Scientific and medical experts, writers, clinical specialists, data managers, biostatisticians, quality and pharmacovigilance professionals work together.
Laboratories, centres and other facilities are selected for the task. We can organise a single-point-of-contact project or share activities with your team and chosen providers.
AboutCan we commission one activity?
Yes. A programme, document, analysis or a defined project stage can be commissioned separately. We agree the scope before starting.
Can we retain some work in-house?
Yes. You can retain selected activities or appoint other providers. Tasks and responsibilities are agreed at the start.
Where do we start?
Tell us about your product and objective. We will assess the available information, identify what is needed and agree the right scope of work.