ElevenGene Labs — Pre-Meeting Qualification

Step 1 of 7 — Identification 14%

Step 1 of 7 · Identification

About you and your company

This information helps us tailor the conversation before the first meeting.

Full name

Job title

Company

Country of origin

Work email

Step 2 of 7 · Product

The product you want to bring to Brazil

Describe what motivated your interest in the Brazilian market.

Product category

Molecular diagnostic kit (qPCR / NGS / ddPCR)

Serological / immunological diagnostic kit

Platform / instrument + reagents

Point-of-care (POC) diagnostic kit

Other

Brief description of the product

Existing regulatory approvals

CE Mark (Europe)

FDA clearance / approval (USA)

NMPA (China)

Registration in another country

No registration yet

Step 3 of 7 · Brazil situation

What do you already have in Brazil today?

This helps us identify exactly where you are in the market entry journey.

Legal presence in Brazil

No legal presence whatsoever

We have an importer / distributor contact (no formal agreement)

We have a registered subsidiary or branch in Brazil

ANVISA regulatory process status

Never initiated — we have no experience with ANVISA

Informally consulted, but no formal petition submitted

Petition in progress

Product already registered with ANVISA

Clinical data with Brazilian patients

No — data available from European / US populations only

Partial — pilot study conducted in Brazil

Yes — complete study with Brazilian population

Step 4 of 7 · Challenges

What are your main anticipated challenges?

Select everything that applies.

We don't understand Brazilian regulation (ANVISA) — it seems complex and slow

We have no reliable local partner or distributor

Our clinical data doesn't cover the Brazilian population

We don't know how to price and position the product in Brazil

We compete against established players — differentiation is difficult

We don't know the real market size for our product in Brazil

We had a negative experience in a previous Brazil entry attempt

Limited budget — we need to prioritize what is truly essential

Any other challenge not listed?

Step 5 of 7 · Impact & Urgency

What happens if these challenges are not resolved?

We want to understand the real business impact.

If the Brazil entry is delayed by 12 months, the impact would be:

Low — Brazil is a secondary market for now

Moderate — we'd lose positioning but could recover

High — a competitor could arrive first and take our space

Critical — Brazil is central to our strategic growth plan

Target timeline for first sales in Brazil

Less than 12 months (urgent)

12 to 18 months

18 to 30 months

More than 30 months — still in planning phase

Expected revenue in Brazil in the first year

Less than USD 500k

USD 500k – 2M

USD 2M – 10M

More than USD 10M

Step 6 of 7 · Needs

What would the ideal outcome look like for you?

Select the support areas most relevant to your situation.

Understanding ANVISA regulation and building the registration dossier

Technical and clinical validation with Brazilian samples

Identifying and formalizing local distribution partners

Defining competitive positioning and strategy in Brazil

Assessing market potential and commercial viability

Ongoing local support after product launch

Technical evaluation for investment or partnership purposes

Available budget for the full market entry journey

Up to USD 30k

USD 30k – 80k

USD 80k – 150k

Above USD 150k

Step 7 of 7 · Decision

About the decision-making process

Helps us prepare the right conversation with the right people.

Are you the final decision-maker for engaging a consultancy?

Yes — I am the final decision-maker

I am an influencer — the decision requires senior approval

I am mapping options to present to the board

Are you evaluating other consultancies or partners?

No — ElevenGene is our first and primary option

Yes — we are evaluating 2 to 3 options

We have not started a formal evaluation yet

Anything specific you'd like the consultant to know before the meeting?

Sending your answers to our team...

Thank you — we're all set.

Your answers have been sent to our team. A consultant will be in touch shortly to confirm your meeting details.

What happens next

Our consultant reviews your profile and prepares a tailored briefing

You'll receive a meeting confirmation within 1 business day

The meeting will be focused entirely on your specific situation — no generic pitches

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