Credevo

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Contact information, map and directions, contact form, opening hours, services, ratings, photos, videos and announcements from Credevo, Health/Medical/ Pharmaceuticals, Singapore.

A global Clinical Trial Organization (CTO) providing comprehensive clinical trial services for pharmaceuticals, biologics, medical devices and healthcare products Credevo provides strategic support for healthcare products including;

- Drugs

- Biologics

- Health Supplements (Nutraceuticals)

- IVD and medical devices

- Cosmetics

In areas of

- Regulatory

- Clinical Development

- Business Development Support

- Licensing (out-/in-)

- Feasibility

13/10/2026

How long a Clinical Study Report (CSR) takes to write depends largely on how many safety narratives it needs.

ICH E3, the international guideline on CSR structure, asks for a written narrative for each death, each other serious adverse event, and those other significant adverse events judged to be of special clinical interest. "Other significant" has a precise meaning in E3: marked laboratory abnormalities that fall short of serious, and any event that led to an intervention such as stopping the study drug, reducing the dose, or adding significant treatment.

Each narrative pulls together the patient's history, dosing, the event's course, concomitant medicines, relevant lab values and outcome, and each one goes through medical review. Two studies with the same design can differ by weeks of CSR effort if one has a handful of qualifying events and the other has sixty, many of them dose reductions.

That count is visible as soon as the safety listings are drafted, so the writing effort can be sized before database lock.

Narrative volume is the first number we ask for when scoping a standalone CSR.

We cover E3 structure and what regional regulators look for here: https://credevo.com/articles/2026/08/25/writing-a-clinical-study-report-in-line-with-ich-e3-structure-common-deficiencies-and-what-apac-regulators-expect/

For a CSR scoping check: https://credevo.com/contact

12/10/2026

A generic inhaler for asthma or chronic obstructive pulmonary disease (COPD) can need a very different evidence package for Europe than for the US, and the difference comes from how each regulator structures the evidence.

Since 1 February 2026, the European Medicines Agency's revised guideline on orally inhaled products uses a stepwise route. If the generic matches the reference on every laboratory (in vitro) criterion, including the particle size profile that decides how deep the drug reaches in the lung, equivalence can be concluded on laboratory data alone. If any criterion fails, the next step is pharmacokinetic studies, which measure drug levels in the blood as a stand-in for both safety and lung deposition. The guideline discourages clinical endpoint studies as too insensitive.

The FDA works product by product. Its current guidance for fluticasone propionate and salmeterol inhalation powder offers two packages: four laboratory studies with two pharmacokinetic studies, or two laboratory studies with one pharmacokinetic study and a comparative clinical endpoint study. It also expects the inactive ingredients and the device to match the reference closely.

Each approach has its own logic, and which package costs less depends on how close the product already sits to the reference in the lab.

Mapping the evidence package for each target market is where our inhalation bioequivalence scoping starts.

For a market-by-market evidence map: https://credevo.com/contact

09/10/2026

A modified-release generic headed for the US should be budgeted for two bioequivalence studies from the start, one fasting and one fed, whatever the reference product's label says about food.

The US Food and Drug Administration's (FDA) guidance on bioequivalence studies for generics recommends both fasting and fed studies for all oral modified-release products, irrespective of the dosing instructions in the reference label. The exception it allows is when serious adverse events are expected under one of the two conditions.

The reason is the formulation. A modified-release tablet holds its dose inside a coating or matrix built to let the drug out over many hours. A high-fat meal changes how long the tablet stays in the stomach and how the gut handles it, and some designs release faster than intended when that happens. A fasting study can pass while the fed study shows a different release profile, so the fed study checks that release holds up when the tablet is taken with food.

Formulation type is the first question in our bioequivalence scoping, because it decides how many studies the quote has to carry.

For a scoping check on a modified-release generic: https://credevo.com/contact

08/10/2026

A generic aimed at both the US and Europe has to show bioequivalence against two different reference products, and that shapes the study plan before the design is discussed.

For a US Abbreviated New Drug Application (ANDA), the US Food and Drug Administration (FDA) selects the reference standard, ordinarily the reference listed drug approved in the US, and the applicant tests against that exact product. The European Medicines Agency's bioequivalence guideline asks for a reference medicinal product authorised in the European Union. The US pack and the EU pack of the same brand can differ in formulation or manufacturing site, so neither regulator accepts one in place of the other.

That means two comparisons. They can run as two studies, or combine in one study with an extra dosing period, where each volunteer receives the test product and both references in turn. Whether combining works depends on the molecule's half-life and variability, because each extra period lengthens the study for every volunteer.

Reference sourcing, including documented purchase of each pack, is the first line item in our bioequivalence scoping.

For a sourcing and design check on a two-market generic: https://credevo.com/contact

07/10/2026

When a team builds an APAC country shortlist, the order of its questions changes which countries stay on the list.

We ask four, in sequence. First the regulatory route: does the product qualify in this market, and by which pathway. Then patient access: can the eligible population be reached at sites that exist. Then site capability for this indication and this protocol. Only then total cost, counted with the delay risk that a long approval or a slow site activation adds.

Each question rules out some markets before the next one is asked. A market with a low per-patient cost drops out at the first step if the product has no workable route there, and a strong regulatory path counts for little without reachable patients. Ranking all markets on one measure skips that filtering, and can give a different shortlist.

Every market on an APAC shortlist suits some studies, and asking the questions in order shows which.

Where does your team start when it builds a shortlist?

For a country shortlist check: https://credevo.com/contact

06/10/2026

India's New Drugs and Clinical Trials (Amendment) Rules, 2026 cut the statutory timeline for a test licence from 90 to 45 working days and removed prior permission for low-risk bioavailability and bioequivalence (BA/BE) studies.

The amendment, notified in January 2026 as G.S.R. 46(E), changes the New Drugs and Clinical Trials Rules, 2019. A test licence is the permission to manufacture a new or investigational drug in small quantities for trials, testing or analysis. Outside a set of higher-risk categories, manufacture can now proceed on an online prior intimation to the Central Drugs Standard Control Organisation (CDSCO) through its SUGAM portal, once acknowledged. Those categories, cytotoxic drugs, narcotic and psychotropic substances, s*x hormones, beta-lactams and biologics with live microorganisms, still need full permission. Low-risk BA/BE studies move to the same intimation and acknowledgment route.

For a sponsor making trial supplies in India, or placing a low-risk bioequivalence study there, the permission step at the front of the plan is now shorter or replaced by an acknowledgment. The 45 working days is a statutory ceiling, and actual turnaround depends on the application.

Tracking CDSCO notifications into our India start-up plans is a standing part of the work.

Timelines are indicative and vary with study specifics and current regulatory requirements.

For an India start-up check: https://credevo.com/contact

05/10/2026

Some performance data for a diagnostic test can come from leftover laboratory samples, with no participants enrolled, so the study type is worth settling before a patient-enrolment study is scoped.

The study type follows from what the evidence has to show and who will judge it. A marketing claim or a drug approval points to a controlled clinical trial with enrolled participants, endpoints fixed in the protocol and a statistical plan locked before data collection. Performance data for an in vitro diagnostic (IVD), such as how reliably the test flags a condition, can sometimes come from analytical studies on leftover residual samples, with no participant enrolled at all, where the regulator's requirements allow it.

The two routes differ in ethics review, cost and time, so the choice is worth making deliberately before a protocol is drafted. The deciding inputs are the claim the sponsor wants to make and the standard its target regulator or journal applies to that claim.

Starting from the objective and working back to the study is how we scope every new project.

For a study-type check before you scope: https://credevo.com/contact

02/10/2026

In Singapore, a Clinical Trial Notification (CTN), the 5-working-day route for lower-risk trials, can only be filed with the Health Sciences Authority (HSA) once Institutional Review Board (IRB) approval is in hand. A Clinical Trial Authorisation (CTA) can be filed in parallel with the IRB submission.

India and Thailand both let the two submissions run side by side, and both tie the regulatory step to the ethics outcome. In India, applications go to the Central Drugs Standard Control Organisation (CDSCO) and the ethics committees concurrently, and CDSCO confirms each site's ethics approval before the study can start. In Thailand, the application can go to the Thai FDA while ethics review is still pending, and the import licence for the study drug depends on proof of approval from a Thai FDA-approved ethics committee.

In all three markets, the regulatory step depends on the ethics decision. For a multi-country plan, the useful question per market is which approval the regulatory step depends on, and when.

Mapping that dependency market by market is the first step in our start-up plans.

Timelines are indicative and vary with study specifics and current regulatory requirements.

Our start-up guide for Asia-Pacific: https://credevo.com/articles/2026/07/05/clinical-trial-start-up-guide-in-asia-pacific-regulatory-timelines-ethics-approval-ec-processes-imp-import-requirements/

For a sequencing check across your markets: https://credevo.com/contact

01/10/2026

A bioequivalence study for a drug with a very long half-life can be run as a parallel-group study, because the gap needed between dosing periods would be too long.

The standard design is a two-period crossover, where each volunteer takes the test product and the reference product in random order. Between the two periods sits a washout. The European Medicines Agency's bioequivalence guideline says that normally takes at least five elimination half-lives, and if a volunteer's drug level before the second dose is above 5 percent of their peak level, that period's data is excluded from the analysis.

Five half-lives is 30 hours for a drug with a 6-hour half-life. For a drug with a 10-day half-life it is 50 days, with every volunteer kept in the study throughout. For substances with very long half-lives, the same guideline allows a parallel design, where each volunteer takes one product only, and it allows exposure to be measured over the first 72 hours after dosing.

A parallel design needs more volunteers. A crossover compares each volunteer with themselves, so differences between people drop out of the comparison. A parallel design has to carry those differences, so the sample is larger.

Half-life is the first number we check when choosing a bioequivalence design.

For a design check on your product: https://credevo.com/contact

30/09/2026

Good Clinical Practice (GCP) certificates from before 2025 do not reflect International Council for Harmonisation (ICH) E6(R3).

That matters when your site staff or study teams passed GCP training under the previous version.

ICH E6(R3) came into effect at the EMA in July 2025 and at the FDA in September 2025. The revision shifts the framework from procedural compliance to a risk-based, quality-by-design approach. What that means in practice is different from what E6(R2) required: how monitoring is structured, what constitutes critical data, how proportionate oversight is defined, and what documentation demonstrates compliance.

A GCP certificate from 2023 shows that the person passed the requirements of the previous version. It does not show that they understand what the current version requires and how to apply it.

Refresher and recertification training covers the gap. Not by repeating the full GCP curriculum. By working through what changed, what the practical implications are for this study and these markets, and what staff trained under the previous version need to update.

Credevo provides GCP refresher and recertification training for CROs, pharmaceutical companies, SMOs, investigator sites, and academic and research institutes. Training is customized to the protocol, the operating markets, and the study team's prior training history.

Available as standalone training or as part of study start-up.

We have covered what quality-by-design means in practice under ICH E6(R3) and what a GCP-compliant quality management system requires at the site and study level.

https://credevo.com/articles/2025/03/15/quality-by-design-in-clinical-trials-building-maintaining-a-qms-framework/

If you are planning GCP refresher training for a study team or site staff ahead of a new program, and want to understand what the E6(R3) transition means for your protocol and markets, we'd be glad to think through it with you: https://credevo.com/contact

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