An A3P × Aktehom initiative

Augmented regulatory intelligence
for the Pharma & Biotech industry

Access, search and analyse binding texts and reference guides in seconds. Every answer is justified, sourced and verifiable.

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28 international sources
4,900+ references indexed
European sovereign AI
RING interface: AI search bar with regulatory filters RING: structured AI answer with references to regulatory texts RING: source document view with page-by-page navigation

Developed in partnership with

A3P: Association for Clean and Sterile Products Aktehom: Regulatory consulting
The reality

From documentary chaos to strategic clarity

Before RING

28 scattered sources, inconsistent formats, outdated versions slipping under the radar

With RING

28 sources unified, continuously updated, structured and searchable in one click

Without RING

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Sources scattered across dozens of institutional websites

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Hours wasted finding the right text in the right version

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Risk of working from an outdated or superseded document

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Interpretation done alone, with no cross-referencing

With RING

✓

One entry point for 28 sources and 1,725 references

✓

Continuous updates. You always work on the latest version

✓

Structured, sourced answers. Every claim is traceable

✓

Targeted alerts on your topics. Nothing slips through

Demo

From question to structured analysis

RING does not generate answers. It searches, cites and justifies. Every piece of information points back to its official source.

What are the Annex 1 requirements for environmental monitoring? How often should autoclaves be revalidated? Differences between FDA and EMA on media fills?
How do I justify a temperature deviation during transport? 21 CFR Part 11: requirements for electronic signatures Grade A particulate thresholds at rest vs in operation
ICH Q9: which risk analysis tools are accepted? What does an FDA inspector check during a data integrity audit? Maximum shelf life for culture media
PIC/S PI 032: requirements for computerised systems Production equipment qualification: IQ/OQ/PQ stages Traceability requirements for critical raw materials
Cleaning and disinfection in Grade B: recommended agents and rotations Recent Warning Letters tied to ineffective CAPAs Cleanroom requalification frequency under Annex 1
Document scope

28 international sources, one entry point

Official documents, technical guides, standards, directives and inspection content: the full pharma & biotech regulatory corpus, structured and up to date.

FDA
Food and Drug Administration
US authority

21 CFR, guidance documents, Warning Letters, Form 483. The most complete inspection corpus on the market.

EMA
European Medicines Agency
European authority

Guidelines, scientific advice, EPAR, regulatory procedures. GMP, GCP and GLP guidance applicable to the EU.

ICH
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
International harmonisation

Q1-Q14 (quality), E-series (efficacy) and S-series (safety) guidelines. The global common foundation.

WHO
World Health Organization
Global organisation

Technical Report Series, GMP for pharmaceutical products, prequalification guidelines.

Swissmedic
Swiss Agency for Therapeutic Products
Swiss authority

Technical requirements, GMP inspections, collaboration with PIC/S and ICH.

EDQM
European Directorate for the Quality of Medicines & HealthCare
Medicines quality

European Pharmacopoeia, reference standards, CEP guidance and certification.

Eudralex
Set of EU regulations for medicinal products
European legislation

Volumes 1-10, GMP Annexes (including Annex 1), European directives and regulations.

PICS
Pharmaceutical Inspection Co-operation Scheme
International inspection

GMP inspection guides, inspector aide-mémoires, harmonised inspection practices across 54 authorities.

BioPhorum
BioPhorum
Biopharma industry forum

Consortium of leading global biopharmaceutical companies. Best practices for bioproduction, process standardisation and operational benchmarks.

IPEC
International Pharmaceutical Excipients Council
Pharmaceutical excipients

Quality standards and good-practice guides for pharmaceutical excipients. The reference for safety evaluation of inactive ingredients.

A3P
Association for Clean and Sterile Products
Field expertise

Good-practice guides, lessons learned, training materials and technical publications from the association.

ANSM
Agence Nationale de Sécurité du Médicament et des Produits de Santé
French authority

Decisions, recommendations, French Good Manufacturing Practices (BPF), national inspections.

APIC
Active Pharmaceutical Ingredient Committee
Active Pharmaceutical Ingredients

GMP guides for the manufacture of chemical and biotechnological APIs. Interpretation of ICH Q7 requirements for active ingredient producers.

PMDA
Pharmaceuticals and Medical Devices Agency
Japanese authority

GMP regulations, marketing authorisation guidelines and inspection requirements specific to Japan.

MFDS
Ministry of Food and Drug Safety
Korean authority

GMP regulations, validation guidelines and drug registration requirements for South Korea.

OECD
Organisation for Economic Co-operation and Development
Good Laboratory Practices

OECD GLP Principles: the international reference standard for the conduct of non-clinical safety studies.

MHRA
Medicines and Healthcare products Regulatory Agency
UK authority

Regulatory guidelines, GxP standards, MHRA Blog, post-Brexit inspection reports.

TGA
Therapeutic Goods Administration
Australian authority

Manufacturing principles, PIC/S adoption, GMP guidelines specific to Oceania.

ASPEC
Association des Salles Propres et Environnements Contrôlés
Cleanrooms (France)

Design, qualification and operation guides for cleanrooms and controlled environments. Field feedback from the French pharmaceutical industry.

Health Canada
Health Canada
Canadian authority

GMP guidelines, inspection guidance and regulatory requirements for Canadian marketing authorisations (DIN).

IPA
Indian Pharmaceutical Alliance
Indian pharma industry

Industry positions and GMP guidance adapted to the Indian production context. Reference for sites exporting to regulated markets.

IPC
Indian Pharmacopeia Commission
Indian Pharmacopoeia

Official monographs, quality standards and analytical methods of the Indian Pharmacopoeia. Regulatory reference for the Indian market.

DKMA
Danish Medicines Agency
Danish authority

GMP regulations, inspection guidelines and national marketing authorisation requirements in Denmark.

Leem
Professional organisation for pharmaceutical companies operating in France
French pharma industry

Industry publications, regulatory positions and market data for pharmaceutical companies operating in France.

NMPA
National Medical Products Administration
Chinese authority

GMP regulations, quality standards and registration requirements for the Chinese pharmaceutical market.

HAS
Haute Autorité de Santé
Health technology assessment (France)

Good-practice recommendations, health-economic evaluations and reimbursement decisions from the French health technology assessment authority.

ANVISA
Agência Nacional de Vigilância Sanitária
Brazilian authority

RDC resolutions, GMP regulations and registration requirements for the Brazilian pharmaceutical market.

NIFDC
National Institutes for Food and Drug Control
Chinese quality control

Official analytical standards and quality control methods for pharmaceuticals. The reference for compliance testing on the Chinese market.

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Selection of the latest referenced publications
Warning letters & Form FDA 483

Learn from past FDA inspections

Ask a question about a process, a site, or a regulatory topic. RING surfaces the relevant FDA inspection findings across 3,000+ indexed Warning Letters and Form 483 observations, then proposes concrete preventive actions for your next audit.

3,000 Warning Letters & Form 483 indexed
1 Your question
What are the risks around environmental monitoring in aseptic manufacturing?
2 Inspection findings surfaced
HVAC contamination Incomplete audit trail Unclosed deviation Particulate monitoring Electronic backup Ineffective CAPA Unqualified media fill 21 CFR Part 11 Equipment qualification Validated cleaning Electronic signatures Change control
3 Preventive actions & insights
Relevant findings

Extraction of FDA findings cited on your topic, with site and inspection date. Benchmark your practice against real, documented cases.

Attention points

The gaps most frequently raised on sites comparable to yours, to prioritise the areas you need to secure.

Preventive actions

Concrete plan for your next audit: controls to reinforce, procedures to review, documents to prepare ahead of time.

Why this matters for your site
QA / Quality Assurance

Anticipate inspector questions by querying the FDA corpus directly on your field.

Validation

Bring FDA inspection findings into your risk analyses and strengthen your validation protocols.

Aseptic manufacturing

Query the FDA inspection corpus on your critical processes to identify points to secure before your next audit.

Continuous monitoring

Proactive monitoring, without the noise

Regulatory texts change every week. RING ingests, analyses and alerts you. You stop watching sources, you simply get informed.

Publication

EMA, FDA, ICH, PIC/S and 23 other sources release new texts

Collection

Daily retrieval of every document

Human

Human validation

Our experts check, classify and approve every document before it enters the base

RING knowledge base

Vectorisation and integration into the AI-searchable index

Targeted alert

Email notification on your topics, with a summary of what changed

Personalisation

Your "Hot Topics" : only what matters for your business

Pick your topics, RING filters the noise. You get real-time alerts on the subjects that impact your daily work.

Pick 2-3 topics relevant to your site:

My monitoring profile
Pick topics above
Trust

Trustworthy AI, built for a demanding industry

Your regulatory data is sensitive. RING is architected to meet the strictest sovereignty, confidentiality and compliance requirements.

European hosting

The platform runs on a dedicated infrastructure in France, operated by Mindexia.

Learn more

The regulatory corpus, your searches and your user data are hosted on a dedicated OVH infrastructure in France. The application layer is deployed in a European region. Native GDPR compliance, operated by a French vendor.

Encryption & auditability

TLS 1.3 in transit, AES-256 at rest, strong authentication, continuous monitoring.

Learn more

All communications are encrypted with TLS 1.3. Data at rest is encrypted with AES-256. The platform runs under continuous monitoring with anomaly detection. Every query and every document view is logged for full auditability, available on request.

Query confidentiality

Your exchanges are never shared, resold or reused. Ephemeral processing on the AI side.

Learn more

Queries sent to the AI models are processed in ephemeral inference mode, with no retention on the provider side. No human access to your searches outside of an explicit support request from you.

Zero ML training

Your queries never train a model. Not today, not tomorrow.

Learn more

RING uses language models in inference mode only, with no fine-tuning or learning on your data. No data feeds a training pipeline.

Alliance

Where network, expertise and technology meet

RING brings together the largest professional network of the pharmaceutical industry, a leading regulatory consulting firm and a sovereign AI technology.

The network

A3P

Association for Clean and Sterile Products

  • 9,000+ members A leading European network dedicated to the healthcare industry
  • Scientific expertise A3P GST technical guides and La Vague magazine, recognised sector references
  • 30 years of field expertise Lessons learned, training, annual conferences
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RING

Augmented regulatory intelligence

The technology

Mindexia

Sovereign knowledge management & generative AI

  • Design & development RING platform architecture, vectorisation and sovereign generative AI
  • Intelligent search RAG pipelines, semantic ranking and verifiable citations
  • Continuous optimisation Ongoing improvement of indexing processes and relevance
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The expertise

Aktehom

Pharmaceutical regulatory consulting

  • Regulatory expertise Consultants specialised in GxP, qualification, validation and data integrity
  • Field support Audits, remediation and training with manufacturers
  • Scope relevance Sources selected and analysed by industry experts
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Testimonials

What the people who use it daily have to say

Quality, regulatory affairs and compliance leads share their experience in their own words.

0 Active users
0 Companies represented
0 Searches run
I really value RING for technical research. The tool links topics to the relevant regulations, surfaces A3P conference materials, and even suggests upcoming A3P events when the topic is on the programme. The interface is well designed and the reasoning is fast.
Jules A3P member
I use RING for regulatory document research, especially when I need the regulation tied to a specific topic. Getting a fast, complete overview of the relevant regulatory texts is very convenient.
Amélie A3P member
The newsletter is an essential monitoring tool. I can't go through every regulatory platform daily, so it brings real ease and fluidity to my work.
Mina A3P member
RING gives me a reliable data source: it gathers verified information from serious documents, without the noise you find elsewhere when substantive articles get drowned in the rest. The content never feels biased or partisan. It's information, nothing else. All in all, an application I trust.
Jérôme A3P member
What I particularly appreciate about RING is the ease with which I can search for technical documents, and how obvious it is that the documents are created on the basis of knowledge from relevant stakeholders in the industry, i.e. sharing of cGMP. More importantly for my role are the regulatory documents and the draft documents, which are easy to find when you browse the country sites.
Mette Marie Juul A3P member
RING is a great help in answering my questions on pharmaceutical regulations worldwide.
Claude A3P member
RING is an extremely useful tool for monitoring and analysing pharmaceutical regulation. It has helped me strengthen compliance on many topics, thanks to the quality of the information, regular updates, and easy access to relevant content. Day to day, it saves me valuable time in regulatory monitoring and helps me anticipate changes that affect our activities. A reliable, structured solution, well suited to sector professionals. Strongly recommended.
Sara A3P member
I value RING for bibliographic searches on regulatory points. RING cites and displays its source documents, which strongly credits the answer; the pictogram with the exact reference (page, paragraph) within the document is very handy. It's a clear productivity gain for research. And by surfacing several document sources, it also helps inform and build sensitivity to other perspectives.
Hervé A3P member
Pricing

Access reserved for A3P members

Two membership plans, each active for one year from the subscription date. Unlimited RING access plus all other A3P membership benefits.

For a whole site

Site Membership

A whole industrial site

Unlimited access for every employee on a manufacturing or supplier site. Pricing indexed on total site headcount.

Site headcount
360 € excl. VAT / year
  • Unlimited RING access for every employee on site
  • La Vague magazine, GST technical guides and A3P documentation library
  • A3P events, congresses and training programmes
  • Common Interest Groups and member directory
  • Active for 1 year from the subscription date
Join and activate RING

Individual Membership

1 member

Personal unlimited access to RING for a regulatory expert, consultant or independent QA.

260 € excl. VAT / year
  • Unlimited RING access for 1 member
  • La Vague magazine, GST technical guides and A3P documentation library
  • A3P events, congresses and training programmes
  • Common Interest Groups and member directory
  • Personal membership, 1 year, non-transferable
Join and activate RING
Ready to start?

Activate your Regulatory Intelligence Guard

Join A3P and get access to RING today.

28 official sources
1,725 references indexed
3,159 Warning Letters
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Contact A3P See membership