Service
Life sciences regulatory counsel.
An outsourced regulatory legal function for pharma, biotech and MedTech under Swiss therapeutic-products law. The firm provides ongoing advisory under the HMG and AMBV, legal review of advertising and integrity-and-transparency rules, Swissmedic correspondence review, promotional-material review, and a fixed monthly allotment of advisory hours, on a retainer rather than a full-time hire.
Who this is for
- Foreign biotech and MedTech companies with a Swiss subsidiary and no in-house Swiss counsel.
- Swiss Series A to C biotechs operating without a general counsel.
- Life-sciences teams that need a standing regulatory legal point of contact without a full-time hire.
What's included
- Ongoing regulatory advisory: standing legal advice under Swiss therapeutic-products law, principally the HMG and the AMBV (the medicinal-products licensing ordinance), on the regulatory questions that arise day to day.
- Advertising and promotional review: legal review of advertising under the HMG advertising rules, which permit professional advertising for all medicinal products directed at prescribers and dispensers and public advertising only for non-prescription medicinal products (Art. 31), and which prohibit, among others, misleading advertising and public advertising for prescription-only medicinal products (Art. 32); the detailed requirements in the advertising ordinance (AWV) are confirmed at engagement.
- Integrity and transparency: advice on the integrity-and-transparency regime governing benefits in connection with therapeutic products (VITH), at the principle level, with specific provisions confirmed at engagement.
- Swissmedic correspondence review: legal review of correspondence with Swissmedic before it is sent, and of authority correspondence received, so the regulatory and legal positions stay aligned.
- Promotional-material legal review: pre-release legal sign-off on promotional and educational material against the applicable advertising and transparency framework.
- Fixed monthly advisory allotment: a defined block of advisory hours each month, so routine regulatory legal questions are answered without per-question fee negotiation.
How it works
- Scoping. The firm maps the client's product portfolio, regulatory footprint and the recurring legal questions the Swiss entity faces.
- Retainer set-up. The firm agrees the monthly advisory allotment and the standing scope in a written engagement letter.
- Ongoing advisory. The firm answers regulatory legal questions and reviews advertising, promotional material and Swissmedic correspondence within the agreed hours.
- Escalation. The firm flags matters that exceed routine advisory and scopes them separately so the retainer stays predictable.
- Tier review. The firm reviews whether a deeper Fractional Head of Regulatory Legal engagement (Tier II) better fits the workload as the company scales.
Indicative pricing
Monthly subscription
from CHF 8,000 / month
Outsourced regulatory legal function on a fixed monthly subscription with a defined scope; beyond-scope advisory at CHF 700 to 950 / hour. A Fractional Head of Regulatory Legal tier is available (see Fractional Counsel).
Indicative starting prices, net and exclusive of Swiss MWST (VAT) where applicable; final fee per written engagement letter.
Frequently asked questions
- What does an outsourced regulatory legal function cover?
- It is a monthly retainer that provides the regulatory legal layer a company would otherwise hire in-house: ongoing advisory under Swiss therapeutic-products law (HMG and AMBV), legal review of advertising and promotional material under the advertising rules and the integrity-and-transparency regime, review of Swissmedic correspondence, and a fixed allotment of advisory hours each month. It is the legal function, not the regulatory-affairs filing function.
- Can promotional material be reviewed for compliance with Swiss advertising rules?
- Yes. The HMG sets the principle that professional advertising is permitted for all medicinal products where it is directed exclusively at people who prescribe or dispense them, while public advertising is permitted only for non-prescription medicinal products (Art. 31), and it lists categories of impermissible advertising, including misleading advertising and public advertising for prescription-only medicinal products (Art. 32). The detailed requirements sit in the advertising ordinance (AWV); those specific provisions are confirmed at engagement. The firm reviews promotional material against this framework before release.
- Is this suitable for a foreign company with a Swiss subsidiary and no in-house counsel?
- Yes. The retainer is designed for foreign biotech and MedTech companies operating through a Swiss subsidiary without local in-house counsel, and for Swiss Series A to C biotechs that have not yet hired a general counsel. It gives the Swiss entity a standing regulatory legal point of contact without the cost of a full-time hire.
- What is the Fractional Head of Regulatory Legal tier?
- Tier II is a deeper engagement in which the firm acts as a fractional Head of Regulatory Legal: a larger monthly time commitment, a standing seat in regulatory decision-making, and broader ownership of the regulatory legal agenda. It sits within the firm's wider fractional-counsel model. The two tiers share the same retainer structure and differ in depth and hours.