Pharmaceuticals

Foresight tracks nitrosamine guidance and the chemical rules on your solvents, propellants and packaging, and runs the projects that follow.

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ProjectsRegulatory horizon scanning

  • Ruth Ellison
  • Diego Serrano
  • Owen Price
Recent alerts scored for Ellerholt’s APIs, tablets and inhalers in the EU, GB and the US, most important first. Choose a row to see its evidence.
AlertWhereRelevance
Covers the nitrosamine limits on two of your tabletsGBPriority
Covers your inhaler propellant and two of your APIsEUPriority
Reaches the solvents in your API synthesisEUPriority
Covers your cartons, blister packs and shipping casesEURelevant
Covers the propellant your US site fillsUSRelevant

MHRA updates nitrosamine guidance

Relevance: Priority

Three years to fix excess nitrosamines

Stage
Guidance updated 25 February 2026
CAPAs
Within 3 years of each limit’s publication
Report
Tell the MHRA if fixes will overrun
MHRA guidance on nitrosamine submissions GOV.UK · February 2026 (opens the source in a new tab)

Choose any alert to see what it says and its source.

Trusted by Fortune 100 organisations to protect global portfolios

Rules reach every step, from suppliers to wastewater

One rule at each step of a typical pharmaceutical organisation, and what it means for you.

  1. Suppliers

    From 2030, your suppliers’ EU quota for HFC inhaler propellants falls to about a fifth of their past sales.

  2. Your sites

    Since April 2024, your plants must minimise exposure to APIs toxic to reproduction under the EU carcinogens at work directive.

  3. Your products

    EU REACH bars medicines holding 0.1% or more of the siloxanes D4, D5 or D6 after 6 June 2031.

  4. Your markets

    Canada’s CEPA notice makes anyone who imported over 100 kg of aspirin in 2025, tablets included, report by March 2027.

  5. Wastewater

    Unless overturned in court, EU wastewater law makes you fund at least 80% of removing medicine residues from late 2028.

Illustrative. The rules that reach your organisation depend on its substances, packaging and markets.

Projects for pharmaceuticals

Each is scoped to your substances, sites and markets, and your expert approves the result.

Understand your exposure

All 7 projects

Meet an obligation

All 9 projects

Keep documents current

All 4 projects

Protect your people

All 2 projects

Keep watch

All 3 projects

Describe the work. Approve what comes back.

Every project runs the same way, whatever the regulation. Here Foresight answers a customer’s substance questionnaire from your own records, and asks your suppliers for the rest.

Illustration of one project. The request reads: Answer this customer’s substance questionnaire from our records, and ask suppliers for what’s missing. Foresight reads the customer’s 86 questions and replies: I’ll answer what I can from your formulations, ask suppliers for the rest, and send you the answers to approve. It plans the work: Read the questionnaire, Match each question to your records, Ask suppliers for the rest, Draft each answer with its source. Your records answer 79 of 86 questions. Foresight asks 3 suppliers for the other 7. Priya Nair, Product Stewardship Manager, checks each answer against its source, such as a supplier’s declaration that no PFAS are intentionally added, and approves the completed questionnaire. The answers go into the customer’s own file, each with its source, ready to send back.

  1. Say what you need in plain words, and share what you already have.

  2. Foresight sets the scope, plans the work and drafts each deliverable with the sources it rests on.

  3. The person you name reviews each deliverable against its sources. Nothing is final until they sign it off.

  4. Approved work comes back ready to use.

Your data, kept secure

Your data is kept in your organisation’s own workspace, separate from every other customer’s. It is encrypted in transit and at rest, including nightly backups, and is not shared with model providers for training. Foresight runs regular penetration tests.

How Foresight protects your data

What pharma teams ask

Does Foresight cover medicines approval?

No. Foresight covers the chemical rules on your solvents, propellants and packaging, and tracks nitrosamine guidance. Your team still makes its own submissions to the medicines regulator.

What do the F-gas rules mean for our inhalers?

From 2030, your suppliers’ EU quota for HFC inhaler propellants falls to about a fifth of their past sales. A PFAS portfolio review also finds which of your propellants and blister films count as PFAS under each definition where you sell.

Can Foresight help with packaging rules?

Yes. A PPWR compliance programme sets out the EU packaging rules for your cartons, blisters and shipping cases, with the medicine exemptions and the evidence for each. Foresight also prepares packaging data for each country’s EPR scheme, including the recyclability ratings GB asks for.

What do you need from us?

A description of the work and the products it covers. Useful inputs include the solvents and reagents your API routes use, your packaging specifications, safety data sheets, the sites you run and the markets you sell into. You also name the people who approve each deliverable.

Tell us the work you need done

Foresight talks through your substances, packaging and markets with you. You’ll see the scope and the price before the project starts.

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