- 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
Life sciences regulation
GAWEL Legal provides outsourced regulatory legal support to pharma, biotech and MedTech companies under the HMG and AMBV, on a retainer. The retainer covers ongoing advice, advertising and integrity review under the AWV and the VITH, and review of Swissmedic correspondence, within a fixed monthly allotment of hours instead of a full-time hire.
- Advice
- Therapeutic-products law
- Review
- Advertising and promotional material
- Correspondence
- Swissmedic communications
A defined monthly allotment of legal advisory hours
Who this is for
Scope
- 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 HMG), and which prohibit, among others, misleading advertising and public advertising for prescription-only medicinal products (Art. 32 HMG); the detailed requirements sit in the advertising ordinance (AWV).
- Integrity and transparency:advice on the integrity-and-transparency regime governing benefits in connection with therapeutic products (VITH)
- 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 review of promotional and educational material, while responsibility for the advertising stays with the person the marketing-authorization holder designates for it (Art. 25 AWV)
- 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 the work proceeds
- Scoping The initial review covers the client's product portfolio, regulatory responsibilities and recurring legal questions facing the Swiss entity.
- Retainer set-up A monthly advisory allotment and a standing scope define the retainer.
- Ongoing advisory The agreed hours cover regulatory legal questions and review of advertising, promotional material and Swissmedic correspondence.
- Escalation Matters beyond routine advisory are identified and scoped separately so the retainer stays predictable.
- Growth As the company grows, the retainer can widen into fractional counsel, with GAWEL Legal as part-time head of regulatory legal.
Fees
Monthly retainer
Outsourced regulatory legal function on a fixed monthly retainer with a defined scope; beyond-scope advice is billed by time. It can widen into fractional counsel.
Questions
- What does an outsourced regulatory legal function cover?
- It is a monthly retainer that covers advice 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 HMG), and it lists categories of impermissible advertising, including misleading advertising and public advertising for prescription-only medicinal products (Art. 32 HMG). The detailed requirements sit in the advertising ordinance (AWV). GAWEL Legal 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.
- Can the retainer grow into a fractional head-of-regulatory-legal arrangement?
- Yes. As fractional counsel, GAWEL Legal acts as part-time head of regulatory legal, with more agreed time each month, regular participation in regulatory decisions and a wider range of regulatory legal matters, on the same retainer structure.
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