Services
Find the right service for your product
Find the right service by what you need and what you get. Each service page lists the rules it covers.
How we work with you
From your product to the work done
Every project follows the same four steps, whichever services you use.
Tell us about your product
What it is, where you want to sell it, and how far along it is.
We find the rules
We tell you which rules apply in each market.
We plan the work
We pick the services you need and plan them around those rules.
We do the work
Each service ends with the reports and files listed under "What you get" below.
Area 1
Regulatory and compliance
Get a product cleared by regulators, and stay ready for inspection.
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Regulatory affairs
Use this when you need a product approved, a licence renewed, or an audit passed.
What you get
- A regulatory route for each market you want to reach
- CDSCO filings, plus support after approval (changes, renewals and label updates)
- US FDA strategy for 510(k), De Novo, IND, NDA and BLA routes
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Compliance audits
Use this when an inspection or client audit is coming, or you want to know where you stand.
What you get
- An audit plan agreed with you before we start
- Mock inspections that follow how a regulator works
- Audits of your sites, systems and suppliers
Area 2
Drug safety
Watch for side effects once a product is in use, and report them on time.
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Pharmacovigilance
Use this when you hold a marketing licence and must track and report side effects.
What you get
- A safety system set up for your products: the PSMF and the SOPs (written step-by-step procedures)
- Case intake from patients, doctors, pharmacists and carers
- Case processing and medical review of each report
Area 3
Clinical trials
Plan and run studies in people, from the study plan to the final report.
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Clinical trials (CRO)
Use this when you need a study in people to prove your product is safe and works.
What you get
- Protocol writing and a feasibility check (can this study be done, where and how fast)
- Ethics committee and CDSCO submissions
- Site selection, set-up and start-up
Area 4
Science and labs
Test products, packaging and germ control in the lab, and test on human cells.
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Accredited labs
Use this when you need stability, packaging, transport or batch release testing.
What you get
- Stability studies at ICH conditions: long-term, intermediate, accelerated and light exposure
- Packaging validation
- Transport validation, including cold chain studies with temperature loggers
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Microbiology studies
Use this when you need preservative, sterility, bioburden or antibacterial testing.
What you get
- Preservative efficacy test (PET) to USP <51>, EP 5.1.3 or IP. We add germs to your product and check the preservative kills them over 28 days.
- Sterility test to USP <71>. We check that a product sold as sterile has no living microbes in it.
- Bioburden and microbial limit tests to USP <61> and <62>. We count the microbes in a product, and check for specific harmful ones.
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Human factors and packaging
Use this when you need usability studies or child-resistant packaging tests.
What you get
- A human factors and usability study plan, built around your users and how they will use the product
- Formative usability studies (early studies that shape the design)
- Summative usability studies (a final study that shows the design is safe to use)
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Organoids and NAMs
Use this when you want early safety or efficacy data from human cells.
What you get
- Patient-derived organoid models, grown from a patient's own cells
- Skin, breast and patient-derived tumour organoid panels
- Custom groups of patient samples for your question
Area 5
Market
Gather evidence from everyday use, plan the launch, and turn new ideas into a plan.
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Real-world evidence
Use this when you need evidence from everyday use, after or alongside a trial.
What you get
- Observational studies: we watch what happens to patients in normal care, without changing their treatment
- Patient registries: an organised record of patients with a condition or product, followed over time
- Hospital data partnerships, set up through our hospital network
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Market access
Use this when your approval is in sight and you need a launch plan.
What you get
- A go-to-market plan linked to your approval timeline
- Product placement and commercial strategy
- Help finding and setting up distributors
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Innovation and strategy
Use this when you have an idea and need a clear first step.
What you get
- A review of the opportunity and of other products in the field
- A roadmap for the science and clinical work
- A regulatory gap assessment: what your evidence shows, and what is missing for approval
Companies we have worked with
See all 40 clients →
Partner hospitals and research sites
See all 62 sites →
Start a conversation
Talk to a regulatory or clinical lead.
Tell us about your medicine, device or product. We will suggest a route to approval in each market you want to reach. We will also tell you which studies you need.