Audit-ready SOPs in days, not quarters.
Chen Global Solutions helps small and mid-sized animal-health, pharmaceutical, biotech and other regulated companies fix messy, outdated or missing procedures. AI speeds up drafting. A DVM with regulatory and quality training reviews every line. Your qualified people keep approval.
100% remote · Fixed scope, fixed price · Delivery in 5–10 business days
| TitleHandling of Temperature Excursions for Cold-Chain Products | |
| Doc No.SOP-QA-014 | Revision · Effective03 · 2026-10-05 |
- On receipt, download the data-logger record before unloading.
- If any reading is outside 2–8 °C, place the shipment in Quarantine and label “ON HOLD”.
- Record the excursion on Form QA-014-F1 within 1 hour.
- Notify QA. QA assesses product impact against approved stability data.
QA-014-F1 Excursion Log · Retained per record-retention SOP-QA-002
Your procedures should reflect how the work is actually done
Documents fell behind the business
New products, new staff and new equipment arrived faster than the SOPs were updated. Now steps are out of date and formats don't match.
An audit or inspection is coming
A regulator, certification body or major customer will ask for controlled, current procedures, training records and evidence that you follow them.
No one has time to write
Your QA lead is busy running quality. A full-time technical writer or large consultancy is more than a small team can justify.
Start with documentation. Grow into automation and intelligence.
Every engagement is delivered remotely, scoped in writing, and reviewed by a subject-matter expert.
SOP & Compliance Documentation
SOP Starter, SOP Sprint, Documentation Gap Snapshot and the monthly Documentation Desk.
Explore → Available nowOverflow Support for Consultants
White-label SOP drafting and document control for regulatory and quality consultancies.
Explore → SpecializationAnimal Health & Veterinary
Documentation written with veterinary science behind it, for manufacturers, distributors, labs and nutrition companies.
Explore → Launching Q4 2026QMS Workflow Automation
Deviation, complaint and CAPA intake, SOP review reminders and training tracking built on tools you already use.
Explore → Launching Q4 2026Food Safety & Preventive Controls
Preventive control plans, prerequisite programs and audit-readiness packs for small food, feed and pet-food makers.
Explore → Free brief now · Paid 2027RegWatch Regulatory Intelligence
Plain-language regulatory updates for your products and markets, tagged by relevance, with a human check before every issue goes out.
Explore →Speed from AI. Judgment from science. Approval stays with you.
Most AI agencies don't know GMP. Most consultants don't use AI well. We sit between the two, and we say clearly where each one's job begins and ends.
- Scientific depth. Founded by a Doctor of Veterinary Medicine with formal training in pharmaceutical regulatory affairs and quality operations.
- Commercial sense. Years of B2B experience in food and consumer-goods operations, so documents are written for the floor, not the shelf.
- Human review, always. AI speeds up first drafts. Every line is checked by an expert, and your qualified personnel keep approval authority.
- Confidential by design. Mutual NDA as standard, no client data used to train AI models, and minimal data retention.
- Fixed scope, fixed price. You know the deliverables, the timeline and the cost before we start.
From scattered files to a controlled set in five steps
Discovery call (20 min)
We learn your products, your regulations, your deadline and what “done” looks like.
Proposal & NDA (within 24 h)
A one-page proposal with two options and a fixed price, plus a mutual NDA.
Walkthrough & document collection
You share existing files and walk us through how the work is really done.
Drafting & expert review
AI-assisted drafts, reviewed line by line. Open questions are flagged for your team to confirm.
Your review, then final delivery
One revision round, then final editable files, PDFs and a document-control index.
Founding-client program: 3 places
Our first three clients receive founding rates (up to 27% off) in exchange for a written testimonial and permission to publish an anonymized case study.
What we do for regulated SMEs
Our services roll out in three stages. The status label on each one tells you what's available today, what launches in the next 60–90 days and what's in development.
Available now
SOP Starter & SOP Sprint
3 to 8 audit-ready SOPs on a consistent template, with a document-control index. Delivered in 5–10 business days.
Details → Available nowDocumentation Gap Snapshot
A review of up to 15 documents against the standard you name, returned as a prioritized fix list.
Details → Available nowDocumentation Desk (monthly)
Ongoing drafting and review capacity (up to 8 hours a month) for SOP updates, work instructions and change control.
Details → Available nowRegulatory & Technical Writing
Work instructions, policies, training materials, technical reports, regulatory summaries and product information summaries.
Details → Available nowConsultant Overflow Support
White-label drafting under your brand and your review, for regulatory and quality consultancies.
Details → SpecializationAnimal-Health Documentation
SOPs, technical literature and training content for veterinary product, feed and pet-health companies.
Details →Launching within 60–90 days (Q4 2026)
QMS Workflow Automation
Intake forms, AI-assisted triage, trackers and reminders for deviations, complaints, CAPAs, SOP reviews and training.
Details → Q4 2026Food Safety & Preventive Control Documentation
Preventive control plans, prerequisite programs, supplier approval, recall and traceability procedures, and audit-readiness packs.
Details → Free · available nowRegulatory Brief (monthly)
A free monthly digest of Canadian and US updates that matter to animal health and life sciences.
Details →In development (2027)
RegWatch Subscription
Tailored regulatory monitoring for your products and markets, with relevance tags, suggested review actions and a searchable archive.
Details → In developmentRegWatch + Market
Adds public competitor and market intelligence: approvals, launches, recalls and tenders.
Details → In developmentSOP Knowledge Assistant
A private “ask our SOPs” assistant that answers staff questions from your approved documents only.
Details →SOP & Compliance Documentation
Clean, consistent, audit-ready procedures, built from how your team actually works and delivered on a fixed timeline.
What you receive
- New or rewritten SOPs on one consistent template (yours or ours)
- A document-control index: number, title, version, owner, effective date, next review date
- Gap notes: missing procedures, records or responsibilities we found along the way
- Editable Word or Google Docs files plus PDFs
- One structured revision round based on your team's review
- 30 days of clarification support after delivery
Who it's for
Canadian and North American companies with 5 to 150 staff:
Anatomy of a Chen Global SOP
Each SOP follows the same structure, so staff always know where to look and auditors see control.
Packages
Up to 3 SOPs, reformatted or rewritten, in 5 business days. Best for a first project or an urgent gap.
5–8 SOPs, a master template and a document-control index, in 10 business days. Best before an audit.
Review of up to 15 documents against the standard you name, with a prioritized fix list and effort estimate.
Up to 8 hours a month for SOP revisions, work instructions, change-control write-ups and review. Cancel with 30 days' notice.
Extra work outside the agreed scope is billed at $85/hour, only with your written approval. Terms: 50% deposit to start, balance on delivery. GST/HST applied where applicable.
Not sure which package fits?
Tell us how many documents you have and when your audit is. We'll recommend the smallest scope that works.
Overflow support for regulatory & quality consultants
You already have the clients. We give you drafting capacity: SOPs, work instructions and document-control work delivered under your brand, for your review and sign-off.
White-label by default
We work behind your brand. Your client relationship stays yours, and we never contact your clients directly unless you ask us to.
Your templates, your rules
We adopt your template, numbering scheme and writing conventions, and flag anything that needs your judgment.
Predictable turnaround
Typical SOP drafts in 3–5 business days, with capacity agreed in advance for your busy periods.
What we take on
- New SOP and work-instruction drafting from your notes or client walkthroughs
- Reformatting legacy documents into your template
- Document-control indexes and review-date schedules
- Training material and quiz drafting from approved SOPs
- First-draft regulatory summaries for your review
How pricing works
Per-document rates or a monthly capacity block, agreed in writing before work starts. Mutual NDA and a subcontractor agreement come as standard.
Documentation with veterinary science behind it
Animal-health products sit at the intersection of veterinary medicine, drug and feed regulation, and commercial reality. Our founder is a Doctor of Veterinary Medicine, so the science in your documents gets checked by someone who understands it.
Animal-health SOPs & work instructions
Receiving and quarantine of veterinary raw materials, cold-chain handling, complaint and adverse-event intake routing, labelling review workflows, distribution and returns.
Technical & training content
Product technical summaries, sales-team training modules, and client-education drafts for review by your licensed veterinarians and regulatory staff.
Feed & pet-food documentation
Preventive control and supplier documentation for feed mills and pet-food makers, delivered through our Food Safety service.
SOP Knowledge Assistant
A private assistant that answers staff questions from your approved SOPs only, and cites the section it used.
Who we work with
QMS workflow automation for teams without an eQMS
Your quality events live in email, spreadsheets and paper. We connect them into simple, reliable workflows on the Microsoft 365 or Google Workspace tools you already pay for, so nothing slips.
Starter workflows
| Workflow | What happens | Who benefits |
|---|---|---|
| Deviation & complaint intake | Structured form → AI extracts product, lot and severity → preliminary summary → routed to QA with a due date | QA, operations |
| CAPA tracker | Actions, owners and due dates in one tracker, with automatic reminders and overdue alerts | QA manager |
| SOP periodic review | Review dates from your document index trigger reminders to owners 60, 30 and 7 days ahead | Document control |
| Training assignment | When an SOP changes revision, affected roles are assigned the update and completion is tracked | HR, supervisors |
| Quality dashboard | Open deviations, CAPA ageing and overdue reviews on one page for management review | Leadership |
How we build
Map
Process-mapping call: current state, pain points, systems.
Build
Automation built in n8n, Make or Power Automate with Airtable, Forms or SharePoint.
Test
Tested with dummy records, with a short test record and user guide.
Support
Go-live, then a monthly check-in and maintenance.
Compliance-aware by design
We start with workflows that support your quality system (intake, triage, reminders, dashboards) while the official GxP record stays in your controlled system. Where electronic records must meet data-integrity and validation expectations (ALCOA+, GAMP 5 concepts, 21 CFR Part 11 for US-regulated work), we scope that explicitly with your QA.
Food safety & preventive control documentation
For small food, feed and pet-food makers who need written preventive controls, clean records and a calm audit, without hiring a full-time food-safety writer.
Preventive Control Plan documentation
Structured documentation aligned to Safe Food for Canadians Regulations expectations and HACCP principles: hazard analysis records, control measures, monitoring, corrective actions and verification.
Prerequisite programs
Sanitation, pest control, supplier approval, allergen control, receiving, storage, maintenance, training and personnel hygiene procedures.
Recall & traceability
Recall procedure, mock-recall template and traceability records that work one step forward and one step back.
Audit-readiness pack
A document index, record checklist and gap list before a CFIA inspection, GFSI-benchmarked audit (e.g., SQF, BRCGS) or customer audit. From $1,500.
Log digitization
Temperature, sanitation and receiving logs moved from paper to simple digital forms with reminders. From $300/month.
Feed & pet food
Where food safety meets animal health: documentation for feed mills and pet-food manufacturers.
Pilot clients wanted
Launching in Q4 2026 with pilot pricing for the first clients.
RegWatch: know what changed, and whether it affects you
Someone at every small regulated company is supposed to watch Health Canada, CFIA, FDA and other regulators. In practice, nobody has time. RegWatch turns those updates into a short, plain-language digest tagged by relevance to your products.
Start free: the monthly Regulatory Brief
Each month: 5–8 updates relevant to animal health, natural health products and life sciences in Canada and the US. Each one gets 2–3 lines on what changed, who's affected and what to review.
- Published on LinkedIn and by email
- No cost, no obligation
- Written and reviewed by a person, with AI assistance
- What changed: a plain-language summary of the update
- Who is affected: the product categories and markets it applies to
- Suggested review: the SOP, label or process worth checking
- Relevance rating: high, medium or low for your business
Planned subscription tiers
One market, monthly digest tailored to your product categories.
2–3 markets, weekly digest, searchable archive and relevance tagging.
Custom source tracking, a quarterly impact briefing call, and optional +Market competitor intelligence.
Planned pricing; final pricing is confirmed at launch. RegWatch is for information. It isn't legal or regulatory advice, and your qualified personnel decide what action to take.
Built for small regulated companies
We focus on SMEs where one person often wears the QA, regulatory and operations hats.
Animal health
Veterinary drugs and biologics, distributors, diagnostic labs, veterinary groups.
Veterinary Drugs Directorate · CFIA · FDA-CVMAnimal nutrition & pet food
Feed mills, premix and supplement makers, pet-food brands.
CFIA feed requirements · SFCR · HACCPNatural health products
Licence holders, contract manufacturers, importers.
Health Canada NHP GMPPharmaceuticals & biotech
Small pharma, biotech start-ups, CDMOs, packaging and distribution.
Health Canada GMP (GUI-0001) · ICH Q9/Q10Medical devices
Early-stage device companies building their quality system.
ISO 13485 document structureFood & beverage
Small processors, co-packers and importers (from Q4 2026).
SFCR preventive controls · GFSI schemesCosmetics
Brands and manufacturers formalizing GMP and complaint handling.
ISO 22716 structureLaboratories
Contract testing and research labs.
ISO/IEC 17025 document structureRegulatory & quality consultancies
Overflow drafting under your brand.
White-labelAI-assisted. Expert-reviewed. Client-approved.
Here's where AI helps, where people decide, and how we protect your information.
| Stage | AI does | Our expert does | You do |
|---|---|---|---|
| Intake | Organizes notes and existing files into a structured outline | Asks the questions a template can't | Share documents and walk us through the process |
| Drafting | Produces a first draft in the agreed template | Checks technical accuracy, whether each step can really be done, roles, records and references | — |
| Review | Checks consistency of terms and numbering | Flags any assumptions for your team to confirm | Answer flagged questions; one revision round |
| Approval | — | Delivers final files and document index | Your qualified personnel approve and issue |
Standards and frameworks we write to
We structure documents to align with the expectations of the frameworks that apply to you, and we cite only real, current references.
Confidentiality & data handling
NDA as standard
A mutual NDA before any documents change hands.
No training on your data
We use AI tools and settings that don't use client content to train models. Identifiers are removed where practical.
Minimal retention
Working files are returned or deleted at project close, as agreed in your contract. We handle personal information in line with Canada's privacy law (PIPEDA).
Our boundaries
We don't provide legal advice, sign off on regulatory submissions, act as your QA approver, or give clinical veterinary advice. We make your team faster and your documents better, and your qualified people make the decisions.
Support that continues after delivery
Documentation only helps if people can use it. Here's what support looks like on every engagement.
| Support item | What's included |
|---|---|
| Onboarding | Kickoff call, shared folder, intake checklist and a named point of contact |
| Response time | Replies within 1 business day () |
| Revision round | One structured revision round on every fixed-price project |
| Post-delivery support | 30 days of clarification questions after final delivery, at no charge |
| Ongoing maintenance | Documentation Desk retainer for revisions, periodic reviews and change control |
| Automation support | Monthly check-in, fixes and small changes for QMS workflows (from Q4 2026) |
| Formats & tools | Microsoft Word and 365, SharePoint, Google Docs and Drive, PDF. We work in your system or deliver into it |
| Service area | . Delivered 100% remotely |
Existing client?
Email your point of contact or use the contact details below. Include the document number in your subject line.
Fixed scope. Fixed price. No surprises.
All prices are in Canadian dollars, before applicable taxes. Founding rates apply to our first clients, in exchange for a testimonial and an anonymized case study.
| Service | Scope | Standard | Founding rate | Status |
|---|---|---|---|---|
| SOP Starter | Up to 3 SOPs · 5 business days | $650 | $475 | Now |
| SOP Sprint | 5–8 SOPs + template + document index · 10 business days | $1,600 | $1,200 | Now |
| Documentation Gap Snapshot | Up to 15 documents reviewed · prioritized fix list | $750 | $550 | Now |
| Documentation Desk | Up to 8 hours/month · cancel with 30 days' notice | $600/mo | $450/mo (3 months) | Now |
| Consultant overflow | Per document or monthly capacity block | Quoted per engagement | Now | |
| QMS Workflow Automation | Per workflow bundle + monthly maintenance | From $1,500 setup · $250–$600/mo | Q4 2026 | |
| Food Safety Audit-Readiness Pack | Document index, record checklist, gap list | From $1,500 | Q4 2026 | |
| Regulatory Brief | Monthly digest | Free | Now | |
| RegWatch subscription | Tailored monitoring, 3 tiers | $149–$699+/mo (planned) | 2027 | |
Payment terms: 50% deposit to start, balance on delivery (net 15). Extra work outside agreed scope: $85/hour, only with your written approval. GST/HST applied where applicable.
Free guidance for small quality teams
Practical help you can use today, whether or not you work with us.
5 signs your SOPs won't survive an audit
Steps nobody actually follows
If operators say “we don't really do it that way,” the document is a liability, not a control.
No revision history or review date
Auditors look for evidence of control: version, effective date, change summary, periodic review.
Responsibilities name people, not roles
When someone leaves, the procedure breaks. Assign roles.
Records aren't defined
If an SOP doesn't say what evidence is produced and where it's kept, you can't prove it was followed.
Inconsistent formats and numbering
Five templates across ten SOPs signals an uncontrolled system, even when the content is good.
Glossary
| Term | Plain meaning |
|---|---|
| SOP | Standard Operating Procedure: the approved way a task is done |
| CAPA | Corrective and Preventive Action: fixing a problem and stopping it recurring |
| Change control | The documented approval of a change before it's made |
| Deviation | Any departure from an approved procedure or specification |
| ALCOA+ | Data-integrity principles: attributable, legible, contemporaneous, original, accurate, and complete, consistent, enduring, available |
| PCP | Preventive Control Plan, required for many food businesses under SFCR |
| QMS | Quality Management System: the policies, procedures and records that together assure quality |
Frequently asked questions
Is AI-written documentation acceptable to regulators?
Regulators assess the content, control and use of your documents, not the software used to draft them. What matters is that procedures are accurate, followed, approved by qualified personnel and kept under document control. That's why every draft gets expert review and your approval.
Will you use our confidential information to train AI?
No. We use tools and settings that don't train on client content, we sign a mutual NDA, and we return or delete working files at project close.
Can you work in our existing template and system?
Yes. We can use your template, numbering and naming conventions and deliver into SharePoint, Google Drive or your eQMS export format.
Do you visit our site?
We deliver 100% remotely. Walkthroughs happen by video call, and you can share photos or short videos of the process.
How fast can you start?
Usually within 5 business days of a signed proposal and deposit.
Do you work outside Canada?
Yes, for clients in . Canadian regulatory frameworks are our home ground, and we also write to US FDA expectations.
Precision documentation for regulated industries
exists so that small regulated companies can have the same documentation quality as large ones, delivered remotely, quickly and at a fair price.
What we believe
- Documents are for people. An SOP only works if the person doing the job can follow it.
- AI is a tool, not an authority. It speeds up drafting. Expertise and accountability stay human.
- Small companies deserve big-company quality. Fixed prices and fast delivery make it accessible.
- Remote works. Clear process, good tools and honest communication beat travel.
Book a 20-minute discovery call
Tell us about your documents, your deadline and your regulations. We'll say honestly whether we can help, and send a one-page proposal within 24 hours.
Delivered 100% remotely to clients in .
Privacy & terms (summary)
Privacy
collects only the contact and project information you choose to share with us, and uses it to respond to you and deliver our services. We don't sell personal information. We handle personal information in line with Canada's Personal Information Protection and Electronic Documents Act (PIPEDA). To access or correct your information, contact us using the details on the Contact page.
Client documents
Client documents are covered by a mutual NDA. They are processed only with tools configured not to train on client content, and are returned or deleted at project close as agreed.
Nature of services
Our services are documentation, writing, automation and information services. They aren't legal advice, regulatory sign-off, quality approval or clinical advice. Clients remain responsible for reviewing, approving and implementing all documents through their qualified personnel.
Pricing
Prices on this site are in Canadian dollars, exclude applicable taxes, and may change. Planned prices for services in development are indicative. The written proposal governs each engagement.