Vici Health Sciences

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

11/12/2024

Patient compliance is a cornerstone of successful healthcare outcomes, and innovative drug delivery systems are transforming how we achieve it.
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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.
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From sustained-release formulations to patient-friendly dosage forms, we dive into the technologies and strategies driving this evolution in pharmaceutical development.
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https://vicihealthsciences.com/patient-compliance-through-drug-delivery-system/
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The development of high-quality medicine utilizing drug delivery systems offers patients and healthcare provider options for improving compliance.

04/12/2024

Dissolution testing is critical for ensuring the quality, consistency, and performance of oral solid dosage forms. In this blog, we discuss:
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- The role of dissolution in drug development
- Best practices for method development and validation
- Regulatory requirements to ensure compliance
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https://vicihealthsciences.com/fda-dissolution-method/
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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.

20/11/2024

Understanding bioequivalence is essential for bringing safe, effective, and affordable generic drugs to market.
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Our latest blog breaks down:
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- 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
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Get the details and take a step closer to approval:
https://vicihealthsciences.com/what-is-bioequivalence/
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It’s important to have a clear understanding of bioequivalence and why it matters when developing generic drug products.

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

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.
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In our latest blog, we explore:
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- Key formulation components
- Different manufacturing processes for OSDs
- Considerations during OSD product development
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LINK: https://vicihealthsciences.com/what-is-oral-solid-dosage/
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Oral solid dosage (OSD) refers to a finished drug product that is available in solid form intended to be administered through the oral cavity.

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

22/10/2024

QC-friendly methods are designed to be robust, reproducible, and easy to transfer from development to routine quality control, ensuring consistency and compliance at every stage.
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https://vicihealthsciences.com/developing-qc-friendly-analytical-methods/
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Our latest blog explores how to create analytical methods that excel in both research and quality control settings, design methods with QC and regulatory criteria in mind, and ultimately ensure seamless method transfer and validation.
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Quality control is an integral part of the drug development process, and the quality of analysis can make a difference in a drug product's safety and efficacy.

17/10/2024

Understanding phase-appropriate validation is essential for streamlining drug development while managing costs. In our latest blog, we explore how tailored validation strategies can help meet regulatory expectations at every stage—without unnecessary complexity or expense. Having the right approach can make all the difference in efficiency and compliance.
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Check out the full post to learn how phase-appropriate validation can support your drug development journey: https://vicihealthsciences.com/phase-appropriate-method-validation/
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Phase-appropriate method validation is a highly valuable approach for the pharmaceutical companies burdened by drug development's complexity.

15/10/2024

Topical drug products are a rapidly growing market in the US today as they play a crucial role in providing targeted relief with minimized systemic exposure. But the development process comes with unique challenges and opportunities.
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In our latest blog post, we explore the "Key Pharmacokinetic Factors in Topical Drug Development" - covering everything from formulation considerations to the regulatory requirements for these dosage forms.
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https://vicihealthsciences.com/pk-considerations-topical-medications/
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Recently in the world of pharmaceutical industry, topical drug products have emerged as a source of interest among manufacturers and consumers and captured a significant market share.

08/10/2024

Ever wonder how materials for clinical trials are made and approved?
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In our latest blog post, we offer an in-depth look at how CDMOs are essential partners in ensuring the success of clinical trials, from material production to navigating FDA regulations.
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https://vicihealthsciences.com/clinical-manufacturing-explained/
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Whether you're in drug development or curious about the process behind clinical trial materials, check out the post to see how CDMOs help make clinical trials possible.
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Explore how CDMOs help develop clinical trial material, ensuring quality and compliance for successful FDA approval.

04/10/2024

Bringing a new drug to market or developing a generic? Understanding the differences between an 𝗡𝗗𝗔 (New Drug Application) and an 𝗔𝗡𝗗𝗔 (Abbreviated New Drug Application) is critical to navigating the FDA approval process.
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In our latest post, we explain the components of each pathway and highlight the key distinctions to help guide your strategy.
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What’s covered:
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- Key differences between NDAs and ANDAs
- Steps involved in each approval process
- Tips for choosing the right pathway
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Read the blog here: https://vicihealthsciences.com/difference-between-nda-and-anda/
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Learn the difference between NDA and ANDA and how the right process can help get new and generic drugs approved efficiently.

30/09/2024

Thank you to everyone who stopped by our table at . It was great to make new connections and meet with fellow professionals in the industry.
We look forward to seeing you again at our next opportunity!
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27/09/2024

Choosing the right partner is one of the most crucial decisions for your project. It's often one that can make or break your drug development program.
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In our latest post, we discuss the "Top 7 Questions to Ask When Choosing the Right CDMO Partner" and insights on what to look for when navigating this critical step.
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https://vicihealthsciences.com/how-to-select-a-cdmo/
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Check out the blog to make sure you're asking the right questions from the start.
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Choosing the wrong CDMO can lead to costly delays and mistakes that will sink a product. This is especially true for small pharma and pharmaceutical startup companies.

24/09/2024

How do you formulate semi-solid or semi-liquid drug products? When is this dosage form most appropriate and what are its challenges?
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In this blog post, we explore:
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🔹 The different types of semi-solid dosage forms (SSDF)
🔹 How they enhance drug delivery and patient care
🔹 Key considerations when formulating this unique dosage form
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To learn more about how SSDFs play a vital role in effective medication delivery, read the full post here: https://vicihealthsciences.com/semi-solid-and-semi-liquid-dosage-forms/
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Discover the benefits and challenges of semi-solid and semi-liquid dosage forms for drug delivery and how they affect treatment outcomes.

19/09/2024

In the world of product development, formulation is much more than just mixing ingredients. It's the backbone of developing safe, effective, and market-ready drug products for new and improved treatment options. From stability to performance and approval, formulation development plays a central role throughout the majority of the development process.

In our latest blog post, we break down the different stages of drug development and explore why formulation development is a key driver of product success.

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

Whether you're new to drug development or in need of formulation development but don't know where to start, we provide valuable insights on how to turn innovative ideas into commercially successful drug products.

As a company specializing in early-stage formulation development, Vici has a proven track record of delivering formulation products from development to post-approval commercialization.

18/09/2024

Vici Health Sciences is exhibiting at the 23rd Annual Contract Pharma Conference on Thursday, September 26 at the Hyatt Regency, New Brunswick, NJ!
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Our Founder and CEO, Anish Dhanarajan, PhD, will be in attendance to discuss Vici's capabilities, answer questions, and connect with you on how Vici can provide high quality, cost-effective drug development solutions for your programs.
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Full details here: https://vicihealthsciences.com/vici-health-exhibiting-at.../
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Visit us at 𝗧𝗮𝗯𝗹𝗲 𝗡𝗼. 𝟭𝟮𝟬 or send us a contact form on our website (https://vicihealthsciences.com/) to schedule a meeting. We look forward to seeing you there!
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Vici Health exhibiting at the Contract Pharma in New Brunswick, NJ September 26-27, 2024

17/09/2024

𝐍𝐚𝐯𝐢𝐠𝐚𝐭𝐢𝐧𝐠 𝐈𝐧𝐧𝐨𝐯𝐚𝐭𝐢𝐨𝐧 𝐓𝐡𝐫𝐨𝐮𝐠𝐡 𝐭𝐡𝐞 𝐅𝐃𝐀’𝐬 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐏𝐚𝐭𝐡𝐰𝐚𝐲𝐬


The drug approval process in and industries can sometimes seem like a daunting maze. Companies can have all the necessary data for their innovation yet still face obstacles in the pipeline simply due to the plethora of specific requirements and checkpoints along the way.
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In our latest blog post, we take a look at the FDA's different approval pathways, break down their requirements, key advantages, and strategic considerations to help you decide which pathway is best suited for your project.
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https://vicihealthsciences.com/505b2-regulatory-pathway/
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Whether you're currently navigating regulatory hurdles or looking for a partner to optimize your drug development strategy, Vici Health Sciences is here to help! Visit us on our website (https://vicihealthsciences.com/) to learn more.


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We at Vici are well-versed in the different regulatory approval pathways and have proven experience in various aspects of 505(b)(2) development programs.