E-signature for pharma, biotech and medical devices
Pharmaceutical laboratories, biotech, medical device manufacturers, CROs (Contract Research Organisations), clinical trial sponsors: sign protocols, CRO/CMO contracts, informed consents and regulatory dossiers online. 21 CFR Part 11, GxP (GCP, GMP, GLP), ICH-E6 R2 and EU regulation 536/2014 (CTR) compliant.
Pharma regulatory requirements
Frequent ANSM, FDA, EMA audits, GxP traceability of documented decisions, mandatory signature of principal investigators, multi-country CRO contracts, informed consents in 12 languages: paper signatures expose to audit findings (FDA Form 483, ANSM inspection letter) and to product approval delays. Certyneo offers FDA-recognised 21 CFR Part 11-compliant signature, GxP and ICH-E6 R2.
Your regulatory documents online
6 use cases covering clinical development, manufacturing and product registration.
Clinical trial protocol
Protocol + amendments signed by sponsor, principal investigator and ethics committee. Native versioning, ICH-E6 R2 §5.5 traceability (Electronic Trial Master File).
Patient informed consent
ICF (Informed Consent Form) translated in 12+ languages, signed by patient and investigator. GDPR art. 9 (health data), Belmont Report and Helsinki Declaration compliant.
CRO / CMO contract
CRO Master Service Agreement, work order, SOW (Statement of Work), CMO/CDMO manufacturing contract. Multi-language, 21 CFR Part 11-compliant audit trail.
Material Transfer Agreement (MTA)
Biological sample transfer between research institutions, biological material transfer agreement compliant with NIH Uniform Biological MTA.
MAA / ANSM / FDA dossier
Common Technical Document (CTD) modules 1-5, variation dossier, IND (Investigational New Drug), CTA (EMA Clinical Trial Application): qualified signature + RFC 3161 timestamping.
Pharmacovigilance notification
Periodic Safety Update Report (PSUR), DSUR (Development Safety Update Report), serious adverse event (SAE) notification: signature with ICSR (Individual Case Safety Report) traceability.
Why Certyneo for pharma
21 CFR Part 11 compliant (FDA)
E-signature recognised by the FDA for IND, NDA, BLA submissions. Tamper-proof audit trail, unique signer identification, access control, manipulation-resistant timestamp sequence.
GxP & ICH-E6 R2
GCP (Good Clinical Practice), GMP (Good Manufacturing Practice), GLP (Good Laboratory Practice): all ICH guidelines applicable to electronic TMF / DMS are supported.
12+ languages for clinical trials
ICF translated and signed in 12+ languages (EN, FR, DE, ES, IT, PT, NL, PL, JA, ZH, AR, RU). Independent versioning per language, native regulatory traceability.
Frequently asked questions — life sciences
- Is Certyneo 21 CFR Part 11 compliant?
- Yes. Our tamper-proof audit-trail architecture, role-based access control, manipulation-resistant timestamp sequence and unique signer identification (login + 2FA + optional biometry) satisfy the requirements of 21 CFR Part 11 Subpart B (Electronic Signatures). We provide a 21 CFR Part 11 compliance attestation within 48h.
- Is e-signature accepted by the ANSM for clinical trials?
- Yes. Qualified e-signature (QES) under eIDAS has been recognised by the ANSM since 2018 for CTAs (Clinical Trial Applications). EU regulation 536/2014 (CTR), in force since 31/01/2022 via the CTIS portal, also accepts advanced (AES) and qualified e-signatures.
- Can patient informed consent be signed electronically?
- Yes. The FDA published a guidance in 2016 (Electronic Informed Consent) authorising e-consent. The ANSM has also accepted e-consent since 2019, provided that (1) patient identification is certain, (2) the patient can ask questions to the investigator, (3) a copy is provided to the patient. Certyneo covers these 3 conditions by default.
- What is the audit-trail retention period?
- Our audit trail is retained for 30 years (recommended duration for clinical trials) or for the residual patent life of the drug (up to 50 years for some orphan drugs). The digital vault is NF Z42-013 qualified and SAE compliant with NF Z42-020.
- Is Certyneo ISO 27001 and ISO 13485 certified?
- Certyneo hosts its data at OVHcloud SecNumCloud (ISO 27001 + SecNumCloud ANSSI qualification). Our own ISO 27001 is in progress for Q4 2026. ISO 13485 (medical devices) is not applicable to a SaaS signature editor, but our 21 CFR Part 11 + GxP compliance is sufficient for software medical device manufacturers.
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