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Vici Health Sciences Formulation development, GMP clinical manufacturing, regulatory filings, preclinical, and much more

When it comes to drug delivery, suppositories offer unique advantages—especially for patients who cannot take oral medic...
28/03/2025

When it comes to drug delivery, suppositories offer unique advantages—especially for patients who cannot take oral medications. From selecting the right base for drug release and stability to manufacturing process optimization, proper formulation development impacts patient compliance and, ultimately, the efficacy of the final product.

Our latest blog dives into the key considerations for suppository formulation development, including base selection and compatibility, base solubility, and stability requirements for regulatory compliance.

https://vicihealthsciences.com/suppository-formulation-development/

Mastering suppository formulation development helps small pharma create effective treatments. Discover key considerations to improve formulations.

Solid state properties of drug products are critical during drug development as they directly influence the efficacy of ...
20/03/2025

Solid state properties of drug products are critical during drug development as they directly influence the efficacy of a formulation. These include factors like solubility, stability, and overall effectiveness. In our latest blog, we explore:

- Solid state properties to consider during formulation
- Different drug forms
- How solid-state properties shape drug efficacy and impact drug performance

https://vicihealthsciences.com/solid-state-properties-of-drugs/

How do solid state properties of drugs impact pharmaceutical development and stability? Learn more here.

As demand for patient-centric drug formulations continues to grow, orally disintegrating tablets (ODTs) are proving to b...
05/03/2025

As demand for patient-centric drug formulations continues to grow, orally disintegrating tablets (ODTs) are proving to be a game-changer in pharmaceutical development, offering convenience and improving patient compliance to treatment plans. But what does it take to develop a successful ODT and how are they different from conventional tablets? In our latest blog, we explore:

✔️ Formulation challenges and how to mitigate them

✔️ Manufacturing considerations for optimized performance

✔️ Why ODTs are shaping the future of oral drug delivery

https://vicihealthsciences.com/orally-disintegrating-tablets-odts/

Orally disintegrating tablets (ODTs) are solid dosage forms that rapidly dissolve in the mouth without the need for water, typically within seconds to a minute.

Have you ever wondered what happens to a drug product after a vial is punctured, a tablet bottle is opened, or a suspens...
07/02/2025

Have you ever wondered what happens to a drug product after a vial is punctured, a tablet bottle is opened, or a suspension is reconstituted? Understanding in-use stability is critical for ensuring that a medication remains safe and effective throughout its intended use period.

https://vicihealthsciences.com/what-is-in-use-stability/

Whether you're developing injectables, oral solids, or other dosage forms, a well-designed in-use stability strategy is necessary to ensure product integrity and, ultimately, patient safety.

An in-use stability study is performed to evaluate the chemical, physical, microbiological, and functional integrity of a pharmaceutical product after it has been opened or used but before it expires.

One of the most fundamental considerations in drug development is determining whether or not the dosage form needs to be...
28/01/2025

One of the most fundamental considerations in drug development is determining whether or not the dosage form needs to be sterile. This decision impacts everything—from manufacturing complexity, regulatory requirements, and even facility design.

https://vicihealthsciences.com/does-your-dosage-form-need-to-be-sterile-key-differences-between-sterile-and-non-sterile-dosage-forms/

In our latest blog, we explore:

✔️ The key differences between sterile and non-sterile dosage forms
✔️ Different methods of sterilization
✔️ Manufacturing challenges and quality control considerations for each approach

Whether you're working on ophthalmics, oral solid dosage forms, or injectables, understanding the nuances of sterile vs. non-sterile is critical for ensuring compliance and, most importantly, patient safety.

we fully understand the ins and outs of formulation development for sterile and nonsterile products and can help you navigate the complex world.

Both the 505(b)(1) and 505(b)(2) pathway are crucial for bringing innovative therapies to market. But understanding the ...
12/12/2024

Both the 505(b)(1) and 505(b)(2) pathway are crucial for bringing innovative therapies to market. But understanding the differences can significantly impact your development strategy, timeline, and budget.

In our latest blog, we break down:
- What distinguishes these pathways.
- When and why to choose one over the other.
- How each impacts clinical requirements, reliance on existing data, and market exclusivity.

Whether you're developing a new chemical entity or leveraging existing data to streamline your process, this post provides the insights you need to make informed decisions for your drug development program.

https://vicihealthsciences.com/505b1-vs-505b2/

Learn the key differences between 505(b)(1) vs 505(b)(2) regulatory pathways and how they impact drug development timelines, costs, and approval success.

Patient compliance is a cornerstone of successful healthcare outcomes, and innovative drug delivery systems are transfor...
11/12/2024

Patient compliance is a cornerstone of successful healthcare outcomes, and innovative drug delivery systems are transforming how we achieve it.

In this blog, we explore a few common obstacles to medication adherence, formulation methods used to improve patient compliance while optimizing therapeutic outcomes, and ultimately improve convenience for the patients.

From sustained-release formulations to patient-friendly dosage forms, we dive into the technologies and strategies driving this evolution in pharmaceutical development.

https://vicihealthsciences.com/patient-compliance-through-drug-delivery-system/


The development of high-quality medicine utilizing drug delivery systems offers patients and healthcare provider options for improving compliance.

Dissolution testing is critical for ensuring the quality, consistency, and performance of oral solid dosage forms. In th...
04/12/2024

Dissolution testing is critical for ensuring the quality, consistency, and performance of oral solid dosage forms. In this blog, we discuss:

- The role of dissolution in drug development
- Best practices for method development and validation
- Regulatory requirements to ensure compliance

https://vicihealthsciences.com/fda-dissolution-method/

Dissolution testing of pharmaceutical drug products is one of the most important tools during drug development and for quality assurance during quality control (QC) release testing.

Understanding bioequivalence is essential for bringing safe, effective, and affordable generic drugs to market. ⁣Our lat...
20/11/2024

Understanding bioequivalence is essential for bringing safe, effective, and affordable generic drugs to market.

Our latest blog breaks down:

- What bioequivalence means in the regulatory context
- How it ensures the safety and efficacy of generic drugs
- Key study designs and methods for demonstrating bioequivalence

Get the details and take a step closer to approval:
https://vicihealthsciences.com/what-is-bioequivalence/


It’s important to have a clear understanding of bioequivalence and why it matters when developing generic drug products.

One of the key complexities in clinical manufacturing is knowing when to integrate current Good Manufacturing Practices ...
15/11/2024

One of the key complexities in clinical manufacturing is knowing when to integrate current Good Manufacturing Practices (cGMP) in drug development. These guidelines play a vital role in establishing standards for quality, consistency, and safety throughout the process.

https://vicihealthsciences.com/integrating-cgmp-in-clinical-manufacturing/

From improving regulatory compliance to streamlining production and mitigating risks, we explore how implementing cGMP principles can lead to smoother, more reliable clinical manufacturing processes and how to determine when it's best to do so.


cGMP stands for Current Good Manufacturing Practices. These are regulations that are enforced by the FDA to ensure that manufacturing systems are designed and monitored to meet quality standards during drug development.

Oral solid dosage forms (OSDs) like tablets and capsules are at the heart of drug delivery, known for their convenience,...
12/11/2024

Oral solid dosage forms (OSDs) like tablets and capsules are at the heart of drug delivery, known for their convenience, stability, and patient compliance. But developing them comes with its own set of challenges and opportunities for innovation.

In our latest blog, we explore:

- Key formulation components
- Different manufacturing processes for OSDs
- Considerations during OSD product development

LINK: https://vicihealthsciences.com/what-is-oral-solid-dosage/

Oral solid dosage (OSD) refers to a finished drug product that is available in solid form intended to be administered through the oral cavity.

Choosing the right partner can mean the difference between just moving forward and accelerating progress in early-stage ...
06/11/2024

Choosing the right partner can mean the difference between just moving forward and accelerating progress in early-stage drug development. Working with an R&D-focused CDMO offers speed, agility, and cost-effectiveness that this stage demands.

In this blog, we explore how partnering with an R&D-focused CDMO is key to building a foundation for success drug development - offering flexibility, expertise, and the tailored support you need from the start.

https://vicihealthsciences.com/choosing-cdmo-partner-for-early-stage-drug-development/


Early-stage drug development is best performed at an R&D-focused CDMO. Initial formulation and small batch manufacturing for proof-of-concept clinical trials require speed, agility, and cost-effectiveness.

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