Medicinal products
Scientific and regulatory work built around your product, from the earliest development decisions to registration and post-approval activities.
Product assessment and development planning
We assess a product, molecule or portfolio, review the available evidence and identify possible development routes.
- A written opinion with options, risks and a gap analysis.
- Assessment of study requirements and potential in vitro or in silico alternatives.
- Manufacturing, quality and inspection requirements, and market prospects.
- Portfolio screening and candidate selection before detailed product assessment.
Development, manufacturing and quality
We assess the full chain, from the source of the API, excipients and intermediates to manufacturing sites and the finished dosage form.
- For generics, risks arising from differences from the originator or reference product, including composition, chirality and manufacturing.
- Document work on specifications, analytical methods, validation and stability.
- Pre-inspection preparation, audits and GMP inspection support.
- Laboratory work at partner facilities or assessed facilities proposed by the client.
Nonclinical and clinical studies
We plan the evidence programme and can support it in full or deliver selected activities.
- Nonclinical study programmes, laboratory coordination, external oversight and applicable GLP audits.
- Full-service clinical trial and real-world research support.
- Data management, biostatistics, PK/PD analysis, reports and publications.
- Preparation of nonclinical and clinical dossier sections.
Dossier preparation and submission
We review source documents, identify gaps and prepare the dossier for the selected jurisdiction.
- Preparation and updates of Modules 1–5, including Module 2 summaries.
- Product information, package leaflets, quality documents and artwork; leaflet user testing.
- Translation, regional adaptation, Chronicle assembly and XML or archive preparation.
- A complete dossier for the client to submit, or Statandocs submission and procedure management.
After registration
Support continues as evidence, manufacturing and regulatory needs change.
- Variation classification and justification, documents, sequence assembly and responses to questions.
- Pharmacovigilance outsourcing or selected services.
- Price registration and re-registration: assessment and supporting justification.
- Evidence and application packages for applicable product lists, including studies and analysis.
How we can support you
An individual document, study, project stage or complete programme. We agree source data, deliverables, timelines and responsibilities before work begins.
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.