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.

Discuss your project All product areas

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

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.

Software

PharmaDockerAvailable product ChronicleAvailable product xClinicaUsed in Statandocs projects PharmaReviewAvailable product PharmaQMSAvailable product OmniEDCAvailable product ModuleTwoInternal use and testing StaccatoInternal use and testing

One 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.

About

Can 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.