40+
Regulatory frameworks that a multi-market chemical company must manage in parallel: REACH, GHS, COSMOS, IFRA, GMP, IVDR...
Pharmaceuticals
and Chemicals
Less bureaucracy, more science.
We automate the document management tasks that consume your teams’ time.
The world’s most regulated sector needs highly efficient operations.
In pharmaceuticals and chemicals, the regulatory burden grows faster than teams. Every batch generates documentation, every market has its own requirements and every system stores information in a different silo.
The result is that highly qualified professionals devote much of their time to operational tasks: collecting data from various systems, preparing technical documentation for customers, consolidating information for audits or answering repetitive queries, while quality, technical and regulatory teams work under constant pressure to keep documentation up to date and ready for any review.
Akaen automates the systems you already use and the most time-consuming document and regulatory workflows: from generating and updating technical documentation to consolidating information for customers, quality teams and compliance. All without changing your protocols or the way you work.
60%
Of quality and regulatory specialists’ time is spent finding, updating and sending documentation rather than analysing and making decisions.
72%
Of non-conformities in external audits have their origin in incorrect, outdated or incomplete documentation.
3–5h
Manual work to prepare and send the documentation of each batch before its shipment to the customer.
Six common operational patterns in pharmaceuticals and chemicals.
SDS and technical data sheets updated manually
Each regulatory change or reclassification of substances requires identifying the affected products, updating the documentation and ensuring the correct version for each market and language. Without automation, the process is fragmented, time consuming and increases the risk of error or non-compliance.
Manually generated COA for each client
When a batch is released, its analytical results must be extracted and adapted to each customer’s format. Different parameters or templates mean recreating the document. With hundreds of batches a month, manual COA preparation becomes difficult to scale.
Technical knowledge lives in people, not systems
Questions about active ingredient compatibility, cosmetic fragrance restrictions or formulation alternatives during a raw-material shortage always reach the same expert. If that person is unavailable, the answer has to wait.
Approval questionnaires without structured response
Many customers send questionnaires with dozens of technical and regulatory questions in different formats. Without a reusable knowledge base, answering requires searching several systems, coordinating teams and spending hours of senior technical specialists’ time.
Quality reporting and CAPA without real-time visibility
Quality KPIs, non-conformity, CAPA and retained batches are often manually consolidated from various systems. The result is periodic reports that consume preparation time and do not always accurately reflect the actual situation when consulted.
Systems that do not speak to each other
ERP, quality system, LIMS and CRM operate in silos. When formulas, specifications, suppliers or analytical results change, the information must be updated by hand in several systems, with more time invested, risk of inconsistencies and less traceability.
Regulatory compliance and automated technical documentation
REACH, GHS, COSMOS, IFRA, GMP, IVDR... In companies with extensive catalogues and international presence, managing the regulatory frameworks that apply to each product, market and channel is not manually sustainable.
We automate the generation, updating and distribution of regulatory documentation for your products. When regulations change, the system identifies affected products, updates data sheets and notifies customers and distributors without manual intervention.
- Automatic generation of SDS and TDS in the target market language
- Bulk documentation updates when regulations or composition change
- Automatic notification to customers and distributors affected by regulatory change
- Central repository of regulatory data sheets: always in current and traceable version
COAs and certificates of analysis by batch without manual intervention
Every released batch needs a certificate of analysis. Each customer wants its own parameters, units and header. Across hundreds of batches a month, manual COA preparation takes a substantial share of the quality team’s time.
When the batch is approved in the LIMS or ERP, the system automatically generates the COA in the client format, signs it if applicable and sends it to the recipient without any intervention or minimal manual review.
- Automatic trigger from LIMS, ERP or batch release system
- Custom format per client: parameters, language, units and template
- Digital signature and automatic sending when the batch is released
- Total Traceability: which COA was sent, when, to whom and in what version
AI assistant on formulas, catalogue and technical documentation
The technical knowledge of a formulation or regulatory team accumulates years of experience in PDFs, formula sheets, ingredient specifications and stability studies. Today, accessing it requires locating the right person at the right time.
We build an AI assistant with access to all your technical documentation. It answers in seconds the questions that currently need an expert: ingredient compatibility, regulatory restrictions on an active ingredient, formulation alternatives or interpretation of analytical results.
- RAG on your own technical and regulatory documentary corpus
- Answers with citation from the source document: traceable, verifiable and auditable
- Accessible to technical, sales and customer service teams from any device
- Knowledge base automatically updated when new data sheets or regulations are added
GxP and CAPA reporting and real-time regulatory traceability
Quality management reports, CAPA reports, or batch KPIs dashboards should be available in real time, not dependent on someone extracting data from ERP to Excel every week.
The system automatically consolidates production, quality and regulatory information, and generates reports ready for submission to management, key customers or regulatory bodies at any time.
- Quality KPIs Dashboard: non-conformity, open CAPA, OOS and retained batches
- Automated batch reports for GMP or ISO audits and annual product reviews
- Consolidation of data for multinational groups from a single source of truth
- Real-time alerts for out-of-specification results, overdue CAPAs or batches awaiting release
From the first meeting to launch in weeks, not months.
01
Diagnosis and prioritisation
We review how your operations work today, where the manual workload is concentrated, which systems are involved and what makes most sense to automate first.
02
Design and validation
We define the workflows, integrations, rules and scope, then validate them with you before building. This gives the project a clear direction, realistic timelines and fewer surprises.
03
Implementation and launch
We develop, test with real data and launch the solution while protecting day-to-day operations. We train the team so everyday use feels natural from day one.
04
Continuous monitoring and improvement
We keep making sure everything works: monitoring, providing support, resolving issues and suggesting improvements based on actual use so the process continues to evolve.
No obligation. A short conversation to understand your situation and see where we can help.
We work with different organisations across the pharmaceutical and chemical ecosystem.
We work with a range of companies at different points in the supply chain. They share the same challenges: critical documentation, multiple systems and constant coordination between teams, customers and markets.
Manufacturers of ingredients and raw materials
Companies that produce, mix or supply critical components and need to move technical and commercial documentation with agility.
Laboratories and brands with their own product
Teams that develop, manufacture or market products and deal daily with quality, regulatory affairs, operations and multiple internal approvals.
Manufacturers for third parties
Organisations that work for multiple clients at the same time and must adapt documentation, formats and flows to different demands according to the account.
Diagnostic and laboratory companies
Companies managing records, validations, batches, incidents and traceability through processes that must remain organised and auditable.
Speciality chemicals and technical products
Businesses with extensive catalogues, industrial customers and a strong reliance on data sheets, certificates, specifications and version changes.
Groups with multiple plants, subsidiaries or markets
Teams that need to coordinate across sites, apply consistent criteria and share information without relying on emails, spreadsheets and manual work.
Solutions we apply in this sector
Intelligent document processing (IDP)
SDS, COA, technical data sheets and regulatory documentation captured and structured automatically.
Knowledge Assistants
Questions about GMP, REACH or pharmacopoeia requirements answered instantly, with traceable document sources.
Autonomous AI Agents
Agents managing batch release, non-conformity alerts and issuing documentation without manual intervention.
We work with you to identify which processes are worth improving.
We assess your operations, identify where improvements make sense and propose a realistic starting point, with no obligation and a focus on operational impact.