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How To Winning the ANVISA Drug Registration Race · DDReg Knowledge Capsule

• 0:00
  Speaker 1: Imagine spending like a billion dollars.
• 0:03
  Speaker 2: Right, and easily a decade of your life.
• 0:05
  Speaker 1: Yeah, exactly, a decade of your life developing this amazing
• 0:09
  Speaker 1: breakthrough biologic. Yeah, and you know, the FDA approves it,
• 0:13
  Speaker 1: the EMA approves it.
• 0:14
  Speaker 2: You've cleared the biggest hurdles.
• 0:15
  Speaker 1: Right, You're completely ready to launch in Latin America's biggest,
• 0:18
  Speaker 1: most lucrative market. But instead of actually reaching patients, your
• 0:23
  Speaker 1: drug is just physically sitting on a dock in some
• 0:25
  Speaker 1: pollo oh man, just expiring. And why because your Portuguese
• 0:30
  Speaker 1: translation of a single manufacturing certificate was missing an authentication stamp.
• 0:36
  Speaker 2: It happens way more often than people think.
• 0:38
  Speaker 1: It's wild. Welcome to DDRAK knowledge Capsule. Today we are
• 0:42
  Speaker 1: diving deep into the drag pharma material to decode Brazil's
• 0:46
  Speaker 1: national health surveillance agency.
• 0:48
  Speaker 2: That are known as and VISA.
• 0:49
  Speaker 1: Exactly and VISA. And if you're a regulatory affairs director
• 0:53
  Speaker 1: or you know, part of a global launch team listening
• 0:55
  Speaker 1: to this, you already know that having the science is
• 0:57
  Speaker 1: really only half the battle, barely half on a right.
• 1:01
  Speaker 1: The other half is ensuring you don't get trapped in
• 1:03
  Speaker 1: this endless regulatory purgatory. So we are going to look
• 1:07
  Speaker 1: at how to master this entry, avoid the systemic traps,
• 1:11
  Speaker 1: and leverage some massive structural changes happening right now. They
• 1:15
  Speaker 1: can drastically cut your time to market.
• 1:17
  Speaker 2: And let's set the stakes right out of the gate here.
• 1:19
  Speaker 2: And Visa is not just some administrative hurdle, no, I
• 1:22
  Speaker 2: mean it is a highly sophisticated gatekeeper. They are protecting
• 1:25
  Speaker 2: over two hundred million citizens while simultaneously attempting to integrate
• 1:30
  Speaker 2: with this wildly complex global health system.
• 1:33
  Speaker 1: Yeah, it's a huge undertaking.
• 1:34
  Speaker 2: You absolutely cannot just walk in with a pristine critical
• 1:38
  Speaker 2: trial from say another jurisdiction and expect the doors to
• 1:42
  Speaker 2: just fly open.
• 1:43
  Speaker 1: You definitely cannot. So let's meet the gatekeepers. And Visa
• 1:46
  Speaker 1: has been around since nineteen ninety nine, and their jurisdiction
• 1:48
  Speaker 1: is just staggering, it really is.
• 1:50
  Speaker 2: I mean they regulate pharmaceuticals, food, cosmetics, medical devices.
• 1:55
  Speaker 1: Basically anything touching human.
• 1:56
  Speaker 2: Health in Brazil exactly, and they have absolute hardline. For example,
• 2:00
  Speaker 2: if your company deals with controlled substances like narcotics or psychotropics,
• 2:05
  Speaker 2: you don't even get to submit a product dossier until
• 2:08
  Speaker 2: you have what's called an AUTOISI summe, especially in praiser
• 2:11
  Speaker 2: an ae right an AE. Without that baseline enterprise authorization,
• 2:17
  Speaker 2: you cannot handle, you cannot produce, you can't even process
• 2:20
  Speaker 2: these materials. Period.
• 2:21
  Speaker 1: Wow.
• 2:21
  Speaker 2: So it's a complete hard stock totally, and it goes
• 2:24
  Speaker 2: beyond just getting an enterprise license. Once you actually have
• 2:27
  Speaker 2: the right to operate, you still have to prove the
• 2:30
  Speaker 2: drug itself is safe, effective and manufactured to standard.
• 2:34
  Speaker 1: Right, which brings us to the actual paperwork.
• 2:36
  Speaker 2: Yes, so, and visa mandates the icch's Common Technical Document format,
• 2:40
  Speaker 2: the CTD.
• 2:41
  Speaker 1: Which most of our listeners are probably intimately familiar with.
• 2:44
  Speaker 2: Oh yeah, compiling module three for manufacturing quality, Module four
• 2:49
  Speaker 2: for non clinical, module five for clinical data. But compiling
• 2:52
  Speaker 2: this for Brazil introduces some really unique friction. How so, well,
• 2:56
  Speaker 2: they are extremely meticulous about local applicability. You can just
• 3:00
  Speaker 2: you taste your European submission.
• 3:01
  Speaker 1: Okay, let's umback this because I like to think of
• 3:04
  Speaker 1: an visa as an extremely exclusive, high security vault.
• 3:08
  Speaker 2: I like that analogy.
• 3:09
  Speaker 1: Right, Having the best science in the world is like
• 3:11
  Speaker 1: holding a billion dollar diamond, But having that diamond doesn't
• 3:14
  Speaker 1: magically get you inside the vault. Yep, you need the
• 3:17
  Speaker 1: exact right paperwork formatted perfectly into those CTD modules, just
• 3:22
  Speaker 1: to walk up to the door. And here is the kicker.
• 3:26
  Speaker 1: They will not let you in alone.
• 3:28
  Speaker 2: This is a huge point.
• 3:29
  Speaker 1: Yeah, the regulations literally dictate that an international applicant has
• 3:34
  Speaker 1: to designate a legally registered local partner in Brazil. You
• 3:38
  Speaker 1: essentially need a local guide who speaks the Balse language,
• 3:41
  Speaker 1: handles the mandatory Portuguese labeling, and walks you inside.
• 3:45
  Speaker 2: I would actually push back slightly on the guide analogy though,
• 3:48
  Speaker 2: oh really, why, because you know guide implies they just
• 3:51
  Speaker 2: show you the way and then leave. The local partner
• 3:53
  Speaker 2: in Brazil isn't just a consultant, They are the legally
• 3:56
  Speaker 2: accountable entity. This raises an important in question. Why can't
• 4:02
  Speaker 2: a massive multinational just manage its Brazilian approvals from I
• 4:07
  Speaker 2: don't know, a corporate headquarters in Switzerland or New Jersey, right?
• 4:11
  Speaker 1: Why do they need someone on the ground.
• 4:12
  Speaker 2: It completely comes down to jurisdictional accountability, and VISA requires
• 4:17
  Speaker 2: a local entity to hold the bag for importation, distribution,
• 4:21
  Speaker 2: marketing authorization, and incredibly importantly, post market.
• 4:24
  Speaker 1: Surveillance, meaning if a safety signal triggers or you know,
• 4:28
  Speaker 1: something goes wrong on Brazilian soil, and Visa needs someone
• 4:32
  Speaker 1: they can legally subpoena within their.
• 4:34
  Speaker 2: Own borders precisely. I mean, they aren't going to chase
• 4:36
  Speaker 2: a shell company across international water.
• 4:38
  Speaker 1: That makes total sense.
• 4:39
  Speaker 2: The local partner bridges that gap between global science and
• 4:42
  Speaker 2: local compliance, and that accountability doesn't just expire once the
• 4:46
  Speaker 2: drug hits the market.
• 4:47
  Speaker 1: No, definitely not. Product registrations in Brazil are valid for ten.
• 4:51
  Speaker 2: Years, which sounds like a comfortably long time.
• 4:53
  Speaker 1: It does until you realize there is this massive trapdoor
• 4:57
  Speaker 1: at the end of it. You have a highly specific
• 5:00
  Speaker 1: six to twelve month window before that ten year expiration
• 5:04
  Speaker 1: date to initiate your renewal.
• 5:05
  Speaker 2: Prep and if you miss that window.
• 5:07
  Speaker 1: Your registration can collapse entirely.
• 5:09
  Speaker 2: Yeah. Imagine the sheer panic of having a top performing
• 5:11
  Speaker 2: biologic just pulled from pharmacy shelves in your largest Latin
• 5:15
  Speaker 2: American market.
• 5:16
  Speaker 1: Just because someone mismanaged a renewal calendar. It's crazy.
• 5:20
  Speaker 2: It requires relentless operational vigilance.
• 5:22
  Speaker 1: So okay, let's say you've secured your local partner, your
• 5:26
  Speaker 1: CTD modules are pristine, and your dossier is submitted. Now
• 5:30
  Speaker 1: you just brace for the weight.
• 5:32
  Speaker 2: The long wait.
• 5:33
  Speaker 1: The baseline standard authorization timeline in Brazil is roughly three
• 5:37
  Speaker 1: hundred and sixty five.
• 5:38
  Speaker 2: Days under ideal circumstances.
• 5:39
  Speaker 1: Yeah, and Visa has the legal right to extend that
• 5:42
  Speaker 1: period by up to one third if their official decision
• 5:45
  Speaker 1: making delays, So you could easily be staring down a
• 5:48
  Speaker 1: sixteen month weight just for standard approval. I mean, if
• 5:51
  Speaker 1: you have a drug targeting a rare, aggressive disease, sixteen
• 5:54
  Speaker 1: months costs lives and it burns massive amounts of capital.
• 5:58
  Speaker 2: Which is exactly why and Visa has fundamentally shifted its approach.
• 6:02
  Speaker 2: They realize that acting as an isolated bottleneck doesn't serve
• 6:06
  Speaker 2: Brazilian public health at all.
• 6:08
  Speaker 1: So what do they do?
• 6:09
  Speaker 2: Well, they established priority review pathways. If your drug meets
• 6:13
  Speaker 2: specific public health criteria, that grueling three hundred and sixty
• 6:18
  Speaker 2: five day timeline gets slashed down to one hundred and
• 6:20
  Speaker 2: twenty days.
• 6:21
  Speaker 1: Wait, let me stop you there. One hundred and twenty
• 6:23
  Speaker 1: day timeline sounds fantastic in a press release, but realistically,
• 6:27
  Speaker 1: does in Visa actually hit that deadline or is that
• 6:31
  Speaker 1: just like an aspirational target that instantly gets derailed the
• 6:34
  Speaker 1: second a reviewer asks for a supplemental document.
• 6:37
  Speaker 2: That is a very fair point of skepticism. I mean,
• 6:39
  Speaker 2: administrative clock stops happen all the time, but the mechanism
• 6:42
  Speaker 2: behind the priority pathway is what really matters here.
• 6:44
  Speaker 1: Okay, how does it work?
• 6:45
  Speaker 2: Specifically, if a manufacturer submits a dossier to en VISA
• 6:49
  Speaker 2: within sixty days of submitting it to another major authority
• 6:52
  Speaker 2: like the FDA or the EMAI, and VISA is legally
• 6:54
  Speaker 2: mandated to hold a formal meeting with that manufacturer. Yeah,
• 6:58
  Speaker 2: it forces a conversation early in the cycle, so even
• 7:01
  Speaker 2: if the clock stops later, you aren't waiting a whole
• 7:04
  Speaker 2: year just to get your first piece of feedback.
• 7:06
  Speaker 1: That changes the dynamic completely. It makes it a dialogue
• 7:08
  Speaker 1: rather than tossing your file into.
• 7:10
  Speaker 2: A black box exactly. And it goes even deeper with
• 7:12
  Speaker 2: the new reliance and expedded pathways, and VISA is now
• 7:17
  Speaker 2: accepting conditional approvals and even quality changes based directly on
• 7:21
  Speaker 2: approvals from strict recognized authorities, so the FDA, EMA Health
• 7:27
  Speaker 2: Canada or Japan's PMDA.
• 7:30
  Speaker 1: It is a massive paradigm shift and we are seeing
• 7:33
  Speaker 1: simplified pathways specifically tailored for biosimilars and biologics too.
• 7:38
  Speaker 2: Yeah, Historically those required immense, redundant clinical trials.
• 7:42
  Speaker 1: But now if a company can provide highly robust comparability
• 7:45
  Speaker 1: data proving their biosimilar matches the reference product chemically and biologically,
• 7:50
  Speaker 1: and Visa actually allows them to bypass certain non clinical
• 7:53
  Speaker 1: and clinical studies entirely.
• 7:55
  Speaker 2: Which is huge for cost and speed.
• 7:57
  Speaker 1: It is, but here's where it gets really interesting. Where
• 8:00
  Speaker 1: imagine a lot of regulatory professionals are going to raise
• 8:02
  Speaker 1: an eyebrow.
• 8:02
  Speaker 2: Okay, let's hear it.
• 8:03
  Speaker 1: If Envisa has a reliance pathway that just piggybacks off
• 8:07
  Speaker 1: the FDA or Health Canada, aren't they just rubber stamping
• 8:11
  Speaker 1: global drugs? I mean, if the FDA has already spent
• 8:14
  Speaker 1: thousands of hours reviewing the clinical data and says it's good,
• 8:17
  Speaker 1: why does in Visa even need one hundred and twenty
• 8:19
  Speaker 1: day review? Why not just make it an automatic import license.
• 8:23
  Speaker 2: That's a great question. But what's fascinating here is that
• 8:26
  Speaker 2: biology and operational logistics are two vastly different things. Okay,
• 8:30
  Speaker 2: and Visa is absolutely not giving up its sovereignty. They
• 8:34
  Speaker 2: are strategically utilizing global clinical data because you know, human
• 8:38
  Speaker 2: biology doesn't change between Toronto and Rio degeneric.
• 8:41
  Speaker 1: Right, the drug works the same in the body.
• 8:42
  Speaker 2: Exactly, but the local supply chain, the stability of the
• 8:46
  Speaker 2: drug in a tropical climate zone, the Portuguese labeling instructions,
• 8:49
  Speaker 2: the local import conditions, those are entirely unique to Brazil.
• 8:53
  Speaker 2: Ah I see so and VISA uses that expedited review
• 8:57
  Speaker 2: period to ensure that while the science is globally validated,
• 8:59
  Speaker 2: the local execution and safety standards are flawless. They trust
• 9:03
  Speaker 2: the global science, but they relentlessly verify the local application.
• 9:06
  Speaker 1: They trust the global science, but verify the local execution.
• 9:10
  Speaker 1: I love that, but if you want to take advantage
• 9:12
  Speaker 1: of these priority pathways, you really have to play by
• 9:15
  Speaker 1: in Visa's newly modernized rules.
• 9:17
  Speaker 2: You definitely do.
• 9:18
  Speaker 1: The entire regulatory landscape in Brazil is shifting right now,
• 9:23
  Speaker 1: Like in twenty twenty five, if you are a cutting
• 9:25
  Speaker 1: edge biotech firm, you cannot fast track your submission. If
• 9:29
  Speaker 1: your internal filing processes are still stuck in the past, we.
• 9:33
  Speaker 2: Are truly watching a total digital transformation. Let's look at
• 9:36
  Speaker 2: Resolution nine fifty four, for instance, which just went into
• 9:39
  Speaker 2: effect on January twenty five, twenty twenty five.
• 9:42
  Speaker 1: That's a big one.
• 9:42
  Speaker 2: It is. This resolution legally limits regulatory submissions to companies
• 9:47
  Speaker 2: operating within the same economic group.
• 9:49
  Speaker 1: And if you're a regulatory director, listening to this resolution
• 9:52
  Speaker 1: nine five four is the one that should probably keep
• 9:54
  Speaker 1: you up at night, absolutely because it means you can
• 9:56
  Speaker 1: no longer rely on a chaotic web of disconnect did
• 10:00
  Speaker 1: third party distributors in Sam Paulo to handle your.
• 10:02
  Speaker 2: Filings exactly previously, you might have multiple overlapping, sometimes completely
• 10:08
  Speaker 2: contradictory registrations submitted by different distributors for the exact same.
• 10:12
  Speaker 1: Core product, which is a nightmare to track.
• 10:14
  Speaker 2: And VISA got totally tired of untangling that mess. By
• 10:18
  Speaker 2: forcing subbissions to stay within the same economic group, the
• 10:21
  Speaker 2: liability rolls directly up to your corporate structure.
• 10:24
  Speaker 1: Which ensures absolute consistency and quality control and pricing compliance
• 10:28
  Speaker 1: across the board.
• 10:29
  Speaker 2: Right. It forces corporate headquarters to actually own their Brazilian operations, and.
• 10:33
  Speaker 1: That ties directly into the ultimate deadline. March thirteenth, twenty
• 10:37
  Speaker 1: twenty five. Yes, on this day, ENVS goes completely paperless.
• 10:41
  Speaker 1: They will only accept digital dossiers via their data VISA
• 10:44
  Speaker 1: system utilizing the ECTD format, so what does this all mean.
• 10:49
  Speaker 2: It's a start contrast when you think about it.
• 10:51
  Speaker 1: Right, until this year, you had incredibly advanced biopharmaceutical companies,
• 10:56
  Speaker 1: I mean companies developing targeted gene therapies whose regulatory teams
• 10:59
  Speaker 1: were still stressing about printing thousands of pages of physical pay.
• 11:03
  Speaker 2: Per forms, binding them correctly, shipping physical boxes to Brasilia.
• 11:08
  Speaker 1: The anxiety of hoping a massive box of paper doesn't
• 11:10
  Speaker 1: get lost in customs just before a filing deadline. It's
• 11:13
  Speaker 1: just absurd, it really is. But this digital modernization brings
• 11:17
  Speaker 1: us to one of the most powerful tools currently available. Kadifa.
• 11:21
  Speaker 2: Yes, Khadifa is a game changer.
• 11:23
  Speaker 1: It's an API GMP certification, a good manufacturing practice certification
• 11:29
  Speaker 1: specifically for your active pharmaceutical ingredients. And it's available to
• 11:33
  Speaker 1: foreign manufacturers.
• 11:35
  Speaker 2: Right and when in VISA audits your API manufacturing process
• 11:38
  Speaker 2: and grants Kadifa, that certification is valid for fifteen to
• 11:42
  Speaker 2: eighteen months.
• 11:42
  Speaker 1: And up to twenty four months for fixed dose combinations.
• 11:45
  Speaker 2: Exactly.
• 11:45
  Speaker 1: I like to think of Kadifa like tsa pre check
• 11:48
  Speaker 1: for your drugs ingredients.
• 11:49
  Speaker 2: Oh, that's a good way to put it, right.
• 11:51
  Speaker 1: Instead of taking off your shoes unpacking your laptop and
• 11:54
  Speaker 1: undergoing this invasive background check every single time you fly,
• 11:57
  Speaker 1: or in this case, every single time you submit a
• 11:59
  Speaker 1: new drug application. You go through an intense audit just once.
• 12:03
  Speaker 2: Just one time.
• 12:04
  Speaker 1: Then for the next eighteen months you basically get to
• 12:07
  Speaker 1: use the fast lane for any final drug product that
• 12:09
  Speaker 1: uses those pre cleared and ingredients. You just transfer the
• 12:12
  Speaker 1: certification across multiple filings. It's like a fast passet in
• 12:16
  Speaker 1: amusement park.
• 12:17
  Speaker 2: That is the perfect way to look at it. And
• 12:19
  Speaker 2: when you synthesize the importance of these three things, so
• 12:23
  Speaker 2: the Data Visa ECTD digital shift, the corporate consolidation of
• 12:26
  Speaker 2: resolution nine to five four, and the CADIFA PreCheck mechanism,
• 12:30
  Speaker 2: what en Visa is actually doing is forcing companies to
• 12:33
  Speaker 2: be completely dossier ready on day one, because the system
• 12:37
  Speaker 2: is entirely digital and interconnected. Now, if your file isn't perfect,
• 12:41
  Speaker 2: the Data Visup Portal essentially just rejects it.
• 12:43
  Speaker 1: Outright, no more grace periods.
• 12:45
  Speaker 2: Right. It drastically reduces the months of administrative back and
• 12:49
  Speaker 2: forth where regulators had to manually ask for missing paperwork.
• 12:53
  Speaker 1: Which sounds beautifully efficient in theory.
• 12:55
  Speaker 2: In theory, yes, let's be.
• 12:57
  Speaker 1: Real perfection in global regulatory filings is incredibly hard to achieve,
• 13:02
  Speaker 1: and the sources make it painfully clear that despite all
• 13:04
  Speaker 1: this digital modernization in these streamline pathways, market entry in
• 13:08
  Speaker 1: Brazil is still fraught with massive potholes. Oh absolutely, there
• 13:12
  Speaker 1: are systemic traps just waiting for you on the.
• 13:14
  Speaker 2: Ground without a doubt. Take the Certificate of Pharmaceutical Product
• 13:17
  Speaker 2: the CPP. The reliance pathways are great, but a visa
• 13:20
  Speaker 2: still mandates the CPP to prove your drug is legally
• 13:24
  Speaker 2: approved in its country of origin.
• 13:25
  Speaker 1: And when a visa asks for your CPP, they aren't
• 13:28
  Speaker 1: just asking for a PDF photocopy that you can email over. No. No,
• 13:32
  Speaker 1: you have to get this physical document formally authenticated by
• 13:36
  Speaker 1: the country of origin.
• 13:37
  Speaker 2: Which is so tedious.
• 13:38
  Speaker 1: You are suddenly at the mercy of a foreign consulate's
• 13:41
  Speaker 1: bureaucratic backlog, just waiting for an apostle stamp, and that
• 13:46
  Speaker 1: can cause significant submission delays before and visa even opens
• 13:50
  Speaker 1: your digital.
• 13:50
  Speaker 2: Dossier, and the administrative friction doesn't stop there at all.
• 13:54
  Speaker 2: The translation burden.
• 13:55
  Speaker 1: Is immense, Oh, the translation.
• 13:57
  Speaker 2: You are not just translating conversational Portuguese, paying to translate
• 14:01
  Speaker 2: thousands of pages of highly technical medical and chemical data
• 14:05
  Speaker 2: into perfect regulatory Portuguese.
• 14:08
  Speaker 1: And any discrepancy can trigger or rejection.
• 14:10
  Speaker 2: Yep, then you have GMP inspection fees, complex import taxes
• 14:14
  Speaker 2: and just the sheer logistical planning required just to get
• 14:17
  Speaker 2: the physical product across the border for testing.
• 14:19
  Speaker 1: And even after you cross the finish line let's say
• 14:22
  Speaker 1: you secure approval, the sources highlight major challenges on the
• 14:25
  Speaker 1: commercial site too, particularly regarding pharmacovigilance and market access.
• 14:31
  Speaker 2: Yes, the real pothole isn't just setting up a PV system,
• 14:34
  Speaker 2: It's that Brazil's localized reporting infrastructure is highly fragmented across
• 14:39
  Speaker 2: massive geographic.
• 14:40
  Speaker 1: States, which causes huge issues.
• 14:42
  Speaker 2: It severely delays your signal detection if an adverse event occurs. Furthermore,
• 14:48
  Speaker 2: companies frequently face post approval payment and access delays, right
• 14:52
  Speaker 2: because just.
• 14:53
  Speaker 1: Because a visa clears your drug doesn't mean the local
• 14:55
  Speaker 1: healthcare system automatically integrates it into their formularies.
• 14:59
  Speaker 2: Exactly, literally have to pursue judicial recourse, like actually going
• 15:03
  Speaker 2: to the courts just to ensure their approved drugs actually
• 15:07
  Speaker 2: reach the patients and that the companies get paid.
• 15:10
  Speaker 1: It sounds so stressful navigating this is honestly like running
• 15:13
  Speaker 1: a relay race, but the baton you're holding is covered
• 15:15
  Speaker 1: in grease and keeps changing shape.
• 15:17
  Speaker 2: That's a great image.
• 15:18
  Speaker 1: It is not just about running fast with great clinical data.
• 15:21
  Speaker 1: It is about navigating translation taxes, understanding complex biosimilar rules,
• 15:27
  Speaker 1: and dealing with local legal nuances without dropping that baton.
• 15:32
  Speaker 1: So how do companies actually win this race? What are
• 15:36
  Speaker 1: the master strategies from the material?
• 15:38
  Speaker 2: If we connect this to the bigger picture, it really
• 15:40
  Speaker 2: requires parallel processing.
• 15:42
  Speaker 1: Okay, what's step one?
• 15:43
  Speaker 2: First? Strategic product categorization is paramount. You have to select
• 15:47
  Speaker 2: the exact right cody godea sunto the specific subject code
• 15:51
  Speaker 2: when you file. If you classify your novel medication incorrectly
• 15:54
  Speaker 2: in the portal, you completely miss out on the priority
• 15:56
  Speaker 2: review pathways.
• 15:57
  Speaker 1: Well just from one wrong code. Yes.
• 16:00
  Speaker 2: Second, you must secure KADIFA early. Do not wait until
• 16:03
  Speaker 2: you are filing your finished product to suddenly realize your
• 16:06
  Speaker 2: API needs a localized GMP certification.
• 16:09
  Speaker 1: Right, get your tsa pre check before you even book.
• 16:11
  Speaker 2: The flight exactly. Third, because Resolution nine five and four
• 16:14
  Speaker 2: limits submissions to your economic group, you must conduct relentless
• 16:18
  Speaker 2: internal audits to make sure everything matches your entire corporate
• 16:21
  Speaker 2: structure has to be aligned to respond to and Visa's
• 16:25
  Speaker 2: information requests instantly. And finally, you have to engage deeply
• 16:30
  Speaker 2: embedded local expertise. You simply cannot navigate this from thousands
• 16:34
  Speaker 2: of miles.
• 16:35
  Speaker 1: Away any boots on the ground.
• 16:36
  Speaker 2: You need Brazilian regulatory partners who intimately understand the unwritten
• 16:41
  Speaker 2: procedural nuances of the data Visa system. Success in Brazil
• 16:45
  Speaker 2: demands that your operational readiness and your scientific strategy move
• 16:48
  Speaker 2: forward simultaneously from day one.
• 16:50
  Speaker 1: You just cannot separate the science from the strategy. No
• 16:54
  Speaker 1: you can't. Let's just briefly recap the journey we've taken
• 16:56
  Speaker 1: today for anyone listening, Brazil represents a phenomenal market opportunity.
• 17:00
  Speaker 1: It's a chance to reach a massive population with life
• 17:03
  Speaker 1: changing pharmaceuticals. But and Visa demands absolute respect for its jurisdiction.
• 17:08
  Speaker 2: They do not mess around.
• 17:09
  Speaker 1: No, from flawlessly compiling your CTD modules to navigating the mandatory,
• 17:14
  Speaker 1: highly accountable local partner requirements, all the way to mastering
• 17:17
  Speaker 1: the new digital only Data Visa era that takes over
• 17:20
  Speaker 1: in March twenty twenty five, you have to respect the
• 17:23
  Speaker 1: system's strict baseline to ever benefit from its fast tracked,
• 17:26
  Speaker 1: cheek codes.
• 17:27
  Speaker 2: But if you do respect that baseline, any strategically utilized
• 17:31
  Speaker 2: tools like the Reliance Pathway and Kadifa, you can actually
• 17:34
  Speaker 2: turn a grueling three hundred and sixty five day weight
• 17:37
  Speaker 2: into a streamlined one hundred and twenty day.
• 17:39
  Speaker 1: Success story, which is incredible.
• 17:41
  Speaker 2: It requires immense upfront operational alignment, but the payoff of
• 17:45
  Speaker 2: entering the Latin American market compliantly is unparalleled, it really is.
• 17:49
  Speaker 1: Before we wrap up, I want to leave you with
• 17:51
  Speaker 1: a final thought to mull over something that builds on
• 17:53
  Speaker 1: this whole concept of the Reliance Pathway. Sure, we are
• 17:57
  Speaker 1: seeing global health agencies like and VISA increasingly rely on
• 18:01
  Speaker 1: data from other major regulators like the FDA and EMA
• 18:04
  Speaker 1: to accelerate their own local access, and it makes you wonder,
• 18:08
  Speaker 1: are we slowly inevitably moving toward a truly unified, borderless
• 18:12
  Speaker 1: global drug approval system.
• 18:14
  Speaker 2: That's a huge question.
• 18:15
  Speaker 1: A future where one rigorous approval basically unlocks the globe,
• 18:19
  Speaker 1: or because of nuanced local supply chains, language barriers, and
• 18:22
  Speaker 1: highly specific regional safety concerns, will we always require an
• 18:25
  Speaker 1: ultimate sovereign local gatekeeper.
• 18:28
  Speaker 2: It is a fascinating tension between global scientific consensus and
• 18:31
  Speaker 2: local security.
• 18:32
  Speaker 1: It really is. Thank you so much for joining us
• 18:35
  Speaker 1: on this deep dive. Keep exploring, keep questioning the world
• 18:38
  Speaker 1: of global health regulations, and we will catch you next time.