Things worth keeping, not things worth downloading once.

Where to start

If you are hiring

Start with the US contract rate guide to set a realistic budget, then use the glossary to make sure the job description asks for the right thing. If the role is tied to a regulatory milestone, check the deadline tracker so the start date works for the programme.

If you are a consultant or looking for a role

The rate guide shows what comparable roles bill across US markets, which is useful before any rate conversation. The checklists and templates are practical working documents you can use on the job. When you are ready, see our open roles or how we place you.

If you run a quality or regulatory function

The deadline tracker and the EU MDR and IVDR material are the quickest way to check where your programme stands against the dates regulators are working to.

How we keep these useful

We keep this list short on purpose. Each resource has an owner in our team, shows when it was last reviewed, and is updated when the underlying regulation, guidance or market data changes. If something looks out of date, or you think a resource is missing, tell us.

These resources are general information, not legal, regulatory or employment advice; see our Disclaimer.

Insights

Insights

Regulatory change, hiring market data and practical notes from programmes we run.

Planned first pieces

• EU MDR and IVDR: what the current deadlines actually mean for legacy devices
• What a compliant I-9 and E-Verify onboarding looks like, and why clients ask
• W2 versus C2C versus 1099 in life sciences contracting, explained for hiring managers
• Life sciences hiring market: what specialist roles are really taking to fill
• Risk-based monitoring: where sponsors still over-invest in SDV
• Five compliance problems that turn up in almost every computerised system validation
• What the second edition of GAMP 5 changed, and what it did not
• 21 CFR Part 11 for computerised system validation, without the jargon
• Where Computer Software Assurance genuinely reduces effort, and where it does not
• How contract specialists shorten a delayed programme, with the trade-offs stated plainly

What we will publish, and how

This section is where we will share practical notes from the work we do: regulatory change that affects how teams plan, what we are seeing in the specialist hiring market, and lessons from validation, clinical and quality programmes. The list above shows the first pieces we are preparing.

Our editorial standards

• Primary sources first. Regulatory statements are checked against the regulation, guidance or authority publication itself, and we link to it.
• Dated and reviewed. Every piece shows when it was written and when it was last reviewed, because regulatory positions and market conditions change.
• Clear about opinion. Where we are giving our view rather than stating a requirement, we say so.
• No client confidences. Examples are anonymised unless a client has approved being named.
• Corrections welcome. If something we publish is wrong or out of date, tell us and we will fix it.

Not advice

Insights are general information to help teams think through a problem. They are not legal, regulatory or medical advice for a specific product or situation; see our Disclaimer. If you need help applying something to your own programme, talk to a specialist.

Until the first pieces go live

Our regulatory deadline tracker, glossary and US contract rate guide are already available and kept up to date.