Classification
Determine the likely product category, risk class, pathway, local-role requirements and submission route.
Philippines-first medical-device regulatory support
Bring your medical product to market with a controlled regulatory plan.
G9C3 helps manufacturers and distributors classify medical products, close submission gaps, organize technical documents, and support market entry with qualified local partners.
Start with a short fit check. Suitable engagements proceed through a defined, paid classification, readiness-assessment or jurisdiction-roadmap scope.
The C3 operating model
Classification. Compliance. Coordination.
One disciplined framework from first pathway decision to a controlled, submission-ready package.
Compliance
Review certificates, quality records, safety and performance evidence, labels, IFUs and dossier completeness.
Coordination
Assign responsibilities and track actions between manufacturers, distributors, laboratories and qualified partners.
What you receiveEvery engagement produces a documented assessment, controlled action list or submission-preparation record appropriate to the agreed scope.
G9 · Nine regulatory markets
One dossier. A wider world.
G9C3 is establishing its principal operating capability in the Philippines. Other jurisdictions are accepted only when the required internal knowledge, qualified local partner and legally appropriate applicant or representative are confirmed.
Philippines
United States
European Union
United Kingdom
Canada
Australia
Singapore
Japan
South Korea
A market shown here is not automatically available for every product or engagement. Scope and partner capability are confirmed before work begins.
Capability map · transparent by design
Know the market. Know the operating model.
The Philippines is G9C3's principal market. International work expands through verified capability and qualified local relationships.
PhilippinesPhilippine FDA
Principal marketUnited StatesU.S. FDA
Partner-supported expansionEuropean UnionEU MDR / IVDR
Partner-supported expansionUnited KingdomMHRA
Partner-supported expansionCanadaHealth Canada
Partner-supported expansionAustraliaTGA
Partner-supported expansionSingaporeHSA
Partner-supported expansionJapanPMDA / MHLW
Capability developmentSouth KoreaMFDS
Capability developmentPhilippines-first pathway
A controlled route from product identity to lifecycle.
- 01Product & intended use
- 02Classification & route
- 03Local role & authority
- 04Dossier, label & evidence
- 05Submission or handover
- 06Tracking & lifecycle
Route details are confirmed for the product and engagement. This diagram is a planning framework, not a representation of government procedure.
Regulatory services
Build the evidence path before you file.
Defined services for manufacturers and distributors that need rigorous regulatory support without building a full in-house department. Deliverables are selected and priced according to the agreed scope.
01
Regulatory strategy
02Clarify the likely classification, regulatory route, local-role requirements, evidence needs and preliminary market-entry assumptions before committing to a full project.
Possible deliverablesClassification assessment · Pathway memorandum · Document checklist · Responsibility matrixReadiness assessment
03Determine whether the available dossier is complete, consistent, current and suitable for the selected submission route.
Possible deliverablesMaster inventory · Completeness assessment · Certificate tracker · Prioritized gap planTechnical dossier organization
04Convert scattered files into a controlled regulatory workspace with clear ownership, version history, indexing and submission status.
Possible deliverablesFolder architecture · Document register · Naming convention · Technical indexLabelling & IFU review
05Compare product names, models, intended use, claims, symbols, warnings and manufacturer details across the label, IFU, certificates and dossier.
Possible deliverablesConsistency matrix · Marked review copy · Missing-information list · Correction trackerSubmission coordination
06Coordinate document requests, administrative preparation, translations, legalization, qualified local-party activities, handover and response tracking.
Possible deliverablesAction tracker · Partner handover record · Correspondence log · Deficiency-response trackerLifecycle support
Maintain control after submission through correspondence, variations, renewals, certificate monitoring and regulatory-document updates.
Possible deliverablesRenewal calendar · Change log · Certificate monitor · Outstanding-risk reportDeliverables may include the items shown above depending on scope. Functions legally reserved for an authorized applicant or qualified local party remain with that party.
The controlled submission system
From scattered files to regulatory control.
G9C3 does more than prepare forms. We build a controlled project system around the product, evidence, responsibilities, decisions and deadlines.
Assess
Inventory the dossier, verify what exists and expose critical gaps.
Organize
Standardize naming, indexing, version history and ownership.
Prepare
Build the administrative and technical package for the correct route.
Coordinate
Track questions, responses and qualified parties to documented outcome.
Regulatory control center · illustrative view
See what is ready. Expose what is missing.
An assessment turns a document pile into a measurable plan with ownership, version history, gap actions and human review.
Sample assessment · RA-2607
Submission readiness
71%
18 verified7 in review4 gap actions
Product & pathwayConfirmed
100%Legal & authorizationIn review
82%Quality evidenceIn review
76%Technical dossierGap actions
64%Label & IFUGap actions
58%Post-market planNot complete
42%Illustrative data only. Every client score is evidence-based and engagement-specific.
Controlled workspace
Human reviewedMaster document register
Manufacturer authorizationManufacturerv2.1Verified
ISO 13485 certificateQuality2026Verified
Device descriptionTechnicalv4.0Review
Risk management fileQualityv3.2Review
Label & IFU setManufacturerv1.8Gap
Eight controlled stages
A visible path from qualification to closure.
- 01
Qualify
Confirm product, market, client authority and available evidence.
- 02
Engage
Define scope, responsibilities, fees and project limitations.
- 03
Activate
Create the project number, controlled folder and action tracker.
- 04
Assess
Review classification, pathway, completeness, labels and risks.
- 05
Remediate
Coordinate corrections, translations and missing evidence.
- 06
Handover
Prepare the authorized applicant or partner for submission.
- 07
Track
Control authority questions, deadlines and deficiency responses.
- 08
Close
Deliver the final archive, risk report and renewal information.
Dossier gap register
CriticalOwnerDue
Label & IFU consistency
NamesModelsClaims
Responsibility matrix
G9C3ClientPartner
Submission timeline
ActionsResponsesDecisions
Samples contain no client information. Actual documents, names and outcomes are never published without written permission.
Honest proof · disclosure controlled
Show the work before claiming the outcome.
G9C3 case studies follow a documented structure. Client names, confidential records, timelines and results are published only when verified and approved in writing.
Dossier control
- Initial condition
- Technical and quality documents are distributed across email, shared drives and uncontrolled folders.
- G9C3 work
- Build a master inventory, naming system, version record, gap register and responsibility matrix.
- Published outcome
- Added only after validation, client approval and removal of confidential information.
Product consistency review
- Initial condition
- Product names, models or intended-use statements differ across certificates, labels, IFUs and technical records.
- G9C3 work
- Compare the complete document set, record each inconsistency and coordinate controlled corrections.
- Published outcome
- Added only after validation, client approval and removal of confidential information.
Deficiency-response coordination
- Initial condition
- Authority questions require evidence and decisions from several organizations under a fixed deadline.
- G9C3 work
- Assign owners, control response versions, record supporting evidence and maintain the correspondence history.
- Published outcome
- Added only after validation, client approval and removal of confidential information.
Product workstreams
Technical evidence changes with the product.
G9C3 structures the regulatory workstream around intended use, product type, risk, available evidence and the selected market.
01
Medical devices
Classification, quality, safety, performance and technical-document readiness.
02
Dental devices
Dental materials, equipment, labels, IFUs and authorization records.
03
In vitro diagnostics
Intended use, performance evidence, labeling and registration strategy.
04
Software & digital health
Software evidence, risk, cybersecurity and human-reviewed AI workstreams.
Independent · Philippines based
Regulatory structure for teams without a full international department.
G9C3 Regulatory Solutions is an independent regulatory consulting and project-management company supporting medical-device, dental-device and IVD manufacturers and distributors.
Who we support
- Foreign manufacturers preparing for Philippine market entry
- Philippine importers and distributors organizing manufacturer evidence
- Small and medium manufacturers without a full regulatory department
- Technical, commercial and country partners needing controlled project support
How we operate
Projects are organized through controlled file names, version histories, action trackers, approval records and communication logs. Country-specific functions are assigned only after partner capability is verified.
What guides the work
AccuracyTransparencyControlIndependenceConfidentialityHuman accountability
Worldwide regulatory advisory team
The people behind G9C3 Regulatory Solutions.
Five regulatory advisors supporting disciplined technical review, market-entry planning and human accountability across G9C3 engagements worldwide.
Kim Trautman PhD
Regulatory Advisor
Caroline Rhim PhD
Regulatory Advisor
Natasha Griffin PhD
Regulatory Advisor
Melissa Hall PhD
Regulatory Advisor
Andrie Udal PhD
Regulatory Advisor
Human accountability network
Every judgment has an owner.
Roles are assigned by scope. Named personnel, technical consultants and country-partner credentials are confirmed in the engagement record.
Founder & managing director
Strategy, regulatory oversight, client relationships and final review.
Regulatory project manager
Timelines, communication, issue control and submission tracking.
Documentation specialist
Inventory, gap support, dossier organization and version control.
Quality reviewer
Independent review, internal audit, corrective actions and data checks.
Qualified partners
Jurisdiction-specific and technical functions confirmed per engagement.
Technology-enabled · Human-accountable
AI accelerates the work. People own the judgment.
AI may help build document inventories, compare product information, prepare trackers, identify possible inconsistencies, summarize records and perform internal formatting checks. Every regulatory conclusion and client-facing output remains subject to qualified human review.
Permitted support
- Inventories, indexes and controlled trackers
- Document comparisons and possible inconsistency flags
- Administrative summaries and internal formatting checks
Never used to
- Invent requirements, data, certificates or evidence
- Make an unreviewed final classification or authority decision
- Replace an authorized signatory or submit unverified information
ControlledAudit trails & versions
Evidence-basedNo fabricated claims
IndependentNo government affiliation
New York officeG9C3 Regulatory Solutions, Inc.41 Madison Avenue
Midtown Manhattan, 31st Floor
New York City, NY 10010, USA
Your first move
Know what is missing before it costs you time.
Tell us about your product, manufacturer, intended use, target market, available certificates, current dossier and desired timeline. G9C3 will determine whether the appropriate next step is a classification assessment, readiness review, jurisdiction roadmap or defined coordination project.
Submissions are processed by FormSubmit and delivered by email to G9C3. Initial contact confirms fit and scope; detailed regulatory analysis is normally performed as a paid professional service.