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Auditing & Consulting · Service

Regulatory assessment to operate without sanctions.

We audit your quality system against INVIMA's mandatory standards. We evaluate suppliers, strengthen your operation, and deliver a concrete action plan before the regulator arrives.

200+Audits completed
15Standards covered
98%Approval rate
Service scope

Three fronts of intervention.

Each front addresses a specific need: meeting standards, securing the value chain, or evaluating a business opportunity.

Mandatory standards

Implementation and Auditing

Assessment and tune-up of the standards your operation must demonstrate to stay in the market. We work on your processes before and after the regulator's visit.

GMP · ManufacturingGWP · WarehousingGDP · DistributionGLP · LaboratoryCCAA
Value chainMost requested

Supplier Management

We evaluate and audit your critical suppliers to ensure they align with your quality system without compromising final product excellence.

Supplier auditingQMS alignmentRemediation planExecutive report
M&A

Due Diligence

Specialized audits of quality and regulatory areas to evaluate companies in acquisition, merger, or expansion processes.

Pre-acquisition regulatoryRisk mapCritical findingsInvestor report
Methodology

Five phases to full conformity.

We don't improvise. Each phase delivers a verifiable result before moving to the next.

01
Assessment

Documentation review

We analyze your portfolio, expiration dates, documentation gaps, and regulatory risks. No assumptions.

02
Plan

Action plan

We prioritize findings, define a timeline, and assign owners. All in writing.

03
Implementation

Tune-up

We implement standards, adjust processes, and train your team on each critical front.

04
Verification

Internal audit

We verify conformity before the regulator's visit. We find what they would find.

05
Follow-up

Continuous monitoring

We monitor regulatory changes, execute remediation plans, and keep your system current.

Service detail

Each service, a clear deliverable.

We don't sell hours. We sell results: a dossier ready, a standard implemented, a supplier audited.

01Implementation and AuditingMandatory standards

Assessment and tune-up of the mandatory standards your operation must demonstrate to stay in the market. We work on your processes before and after the regulator's visit.

Best forPlants in certification · Scheduled audits
Estimated time4-12 weeks
02Supplier ManagementValue chain

We evaluate and audit your critical suppliers to ensure they align with your quality system without compromising final product excellence.

Best forCritical supply chains · International suppliers
Estimated timePer supplier
03Due DiligenceM&A

Specialized audits of quality and regulatory areas to evaluate companies in acquisition, merger, or expansion processes.

Best forM&A processes · Investors · Expansion
Estimated time2-6 weeks
04Corporate TrainingTraining

Tailored training programs to maintain your staff's competencies and ensure continuous improvement in your processes.

Best forInternal regulatory teams · Operational staff
Estimated timePer program
Credentials

Results you can verify.

0
Audits completed
in 18 years
0
Approval rate
on first visit
0
Standards covered
GMP, GWP, GDP, GLP, CCAA
0
Years of experience
Bogotá, since 2008

Certified auditors

Our team holds current certifications in GMP, GWP standards and quality management systems.

Proven methodology

18 years refining a diagnostic process that anticipates findings before INVIMA's visit.

Executive report

Each audit delivers a document with findings, evidence, and a prioritized action plan.

Next step

Request a no-cost assessment of your operation.

We review your current standards, identify gaps, and deliver a clear compliance path. No commitments, no upfront cost.