ALPI Solutions

12/18/2025

ASHP Midyear 2025 — what stood out most

Last week in Las Vegas showed how fast the pharmacy industry is changing.

A few key takeaways we at ALPI Solutions noticed:

• Pharmacy is moving far beyond dispensing — toward clinical expertise and data-driven care
• Digital health, automation, and robotics are no longer “future ideas” — hospitals are already using them
• Regulatory affairs and safety now require strategic and technology-based solutions, not just compliance
• Pharma companies are looking for partners who can connect clinical practice, regulation, and market strategy

For us, ASHP Midyear 2025 became a real turning point in understanding where the industry is heading.

📌 I shared a deeper breakdown of trends and insights in my Medium article:
👉 https://medium.com/.kosulina82/why-ashp-midyear-2025-became-a-turning-point-for-the-pharmacy-industry-trends-technologies-and-69ceeb7c9417

Would love to hear your thoughts — what caught your attention most this year?

The ASHP Midyear Clinical Meeting & Exhibition has long been recognized as the world’s largest event for clinical pharmacy professionals…

12/11/2025

ALPI Solutions — December Highlights 🌟

The year is coming to an end, but the pharma industry is moving faster than ever. This week brought several updates that will shape the upcoming year — and we’re excited to help companies stay ahead.

✨ FDA updates RWE/RWD expectations
More clarity, more structure — and more opportunities for companies that know how to use real-world data correctly.

✨ GLP-1 combinations are the trend of 2026
The demand keeps growing, and new combination therapies are already in development.
ALPI Solutions is helping clients plan their next steps.

✨ EMA accelerates innovation access
A new reliance framework means faster decisions and smoother launches in Europe.

✨ Personalized supplements are booming
Microbiome, hormones, genetics — personalization is becoming the new standard.
We’re expanding our consulting services in this segment.

If you’re planning new launches or regulatory updates in 2026, ALPI Solutions is here to guide you.
Let’s build your strategy together.

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12/04/2025

Hello December! ❄️

For ALPI Solutions, December is the month of clarity and planning.
We help pharma and biotech teams wrap up their year with confidence — from regulatory strategy to market access and product launch support.

In December our consultants focus on:

✨ Preparing documents for FDA & EMA
✨ Supporting teams with market research and competitive analysis
✨ Planning product launches for 2026
✨ Strengthening compliance and QMS documentation
✨ Helping teams navigate complex regulatory questions

If your company needs expert support before the year ends — or wants to start 2026 with a strong strategy — ALPI is here for you.

Wishing everyone a productive, inspiring, and successful December!
— ALPI Solutions

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11/25/2025

As we approach the end of 2025, the regulatory landscape continues to evolve — and staying ahead is essential for every pharmaceutical company. Here are the key updates we’re tracking this week at ALPI SOLUTIONS:

1️⃣ FDA’s PreCheck Expansion Gains Momentum

Pharmaceutical organizations are urging the FDA to expand its PreCheck initiative — a program designed to streamline inspections and accelerate product release.
This could significantly shorten time-to-market for manufacturers prepared to meet the updated expectations.

Our perspective:
At ALPI SOLUTIONS, we help companies optimize readiness for pre-approval inspections and align with evolving FDA expectations.

2️⃣ Global Trends Shaping Regulatory Affairs in 2025

Industry analysts highlight several major trends impacting regulatory teams worldwide:
• Integration of AI and digital tools
• Sustainability and ESG-driven regulatory requirements
• Movement toward harmonized global standards

Our perspective:
Staying compliant now means staying adaptable. We support organizations in building forward-looking regulatory strategies that match the pace of global change.

3️⃣ International Update: ICH Q3E (Extractables & Leachables)

A new consultation period for ICH Q3E opened on November 19, 2025 — an important development for manufacturers of pharmaceuticals, packaging, and combination products.

Our perspective:
Extractables & Leachables compliance is becoming more central than ever. ALPI SOLUTIONS provides scientific and regulatory support for E&L assessments, toxicology reviews, and dossier preparation.

Why this matters

The most successful companies are the ones that adjust early.
If your team needs support with:
✔ Regulatory strategy
✔ Market access
✔ Pre-approval readiness
✔ Documentation and submissions
✔ Global compliance monitoring
We’re here to help.

📩 Contact us to discuss your project or request a consultation.

11/20/2025

Digital Transformation in Pharmaceutical Manufacturing

Rising regulatory pressure, sustainability targets, and growing operational inefficiencies are pushing pharmaceutical manufacturers toward a new phase of digital transformation.

According to today’s industry report, one of the fastest ways to achieve measurable progress is by modernizing print & packaging processes — often overlooked, yet critical for compliance, traceability, agility, and patient safety.

Key insights:
🔹 Legacy print and packaging systems are becoming major risk points
🔹 Digital printing reduces waste, eliminates pre-printed stock, and improves line efficiency
🔹 Connected TIJ/TTO solutions enable cloud integration and real-time customization
🔹 Smart 2D codes unlock full traceability and better patient engagement
🔹 These upgrades offer quick ROI and can be implemented during routine line validation

At ALPI Solutions, we help pharma companies adapt to these shifts — aligning digital adoption with regulatory expectations and quality strategy.

If your organization is exploring digital-first manufacturing or packaging modernization, we’re here to support.

11/13/2025

New Week — New Trends in Pharma

At ALPI Solutions, we keep a close eye on key changes shaping the pharmaceutical industry — and share what truly matters.

💡 Top stories this week:
1️⃣ FDA removes “black box” warnings from hormone therapies for menopause.
This decision makes treatment more accessible and safer, changing labeling strategies and how we communicate with patients.

2️⃣ Digital transformation in pharma is accelerating.
AI, digital twins, automation, and smart manufacturing are no longer the future — they’re redefining how competitive companies operate today.

At ALPI Solutions, we help pharma companies stay ahead of these shifts — from regulatory strategy to digital innovation.

11/06/2025

🇺🇸 FDA simplifies the path: biosimilars and generics to reach the U.S. market faster

Major changes are on the horizon for the pharmaceutical industry.

The FDA has announced that some biosimilars will no longer require large-scale clinical trials if analytical data prove their equivalence.

In addition, a new fast-track review program for U.S.-made generics will promote local manufacturing and strengthen supply chain resilience.

This is great news for manufacturers aiming to bring their products to the U.S. market more efficiently — and for patients who will gain faster access to high-quality, affordable medicines.

At ALPI Solutions, we continuously monitor regulatory updates and help companies adapt to evolving FDA requirements — from dossier preparation to registration strategies and compliance support.

🔗 Want to understand how these initiatives may impact your project? Let’s talk.

10/30/2025

FDA speeds up drug approvals!
What does it mean for pharma teams?
When regulators move faster, companies must move smarter.
Regulatory Affairs and Field Force teams now need to act as one —
updating materials quickly, responding to changes, and keeping healthcare providers informed.
💡 At ALPI Solutions, we track such updates to help our partners
stay compliant, agile, and ready for the market.

10/23/2025

🔥 Big news from the U.S. pharma market: President Trump just announced that Ozempic — one of the most in-demand weight-loss drugs — should drop in price from $1,000 to $150 per month 😮.

For pharma giants like Novo Nordisk and Eli Lilly, this could change everything. Stock prices are already falling 📉, and the industry is facing a new era of strict pricing expectations.

💡 What does it mean? Companies will have to rethink how they operate — from R&D investment planning to how field teams communicate value to doctors and payers. Flexibility, sharp analytics, and strategic adaptability will define who stays strong in this new reality.

10/14/2025

Regulatory Insight:
How the U.S. Government Shutdown Could Affect FDA Review Timelines and Product Launch Strategies

The ongoing U.S. government shutdown is not only a political event — it’s a regulatory one.
While essential FDA functions (such as drug safety surveillance and emergency approvals) continue, most review and administrative processes are either delayed or paused.

🔹 IND and NDA reviews may experience significant slowdowns
🔹 Meetings with FDA reviewers are being postponed or cancelled
🔹 New regulatory submissions could be accepted but not processed until funding resumes

For pharmaceutical and biotech companies, this means rethinking launch strategies, adjusting clinical timelines, and planning contingencies for delayed approvals.

At ALPI Solutions, we help clients evaluate how regulatory disruptions like this can impact their commercialization path — and develop adaptive strategies to stay on track.

📊 Flexibility and proactive communication with regulators remain key during uncertain times.

10/09/2025

Can Artificial Intelligence make pharma submissions faster and safer? Absolutely.
What once took months of manual document review is now being transformed by smart systems that read, compare, and predict with incredible accuracy.
Here’s how AI is helping regulatory teams today:
- Automatically preparing dossier sections and labeling drafts
- Monitoring FDA and EMA updates in real time
- Predicting risks before submission
- Checking documents for consistency and compliance
At ALPI Solutions, we believe AI won’t replace experts — it will empower them.
Together, technology and human insight are shaping the next generation of Regulatory Affairs — where innovation meets responsibility.
🌍 Precision. Compliance. Intelligence.

10/03/2025

✨ ALPI Solutions at Pack Expo Las Vegas 2025 ✨

This week our team visited one of the world’s largest packaging and automation events — Pack Expo Las Vegas 2025. It was an incredible opportunity to explore new technologies that are shaping the future of pharmaceuticals.

🔹 What impressed us most?
• Automation: robotic systems that inspect and package thousands of tablets in seconds.
• Digitalization: AI and track-and-trace tools that protect patients from counterfeit medicines.
• Sustainability: eco-friendly packaging solutions that also meet strict pharma regulations.

For pharmaceutical companies, these innovations are not just “nice to have.” They are becoming the standard for safe, efficient, and trusted healthcare.

At ALPI Solutions, we believe that the future of pharma packaging will be built on automation, digital tools, and sustainability — and we are excited to bring these insights to our partners and clients worldwide.

📸 [Insert your photos from the exhibition here]

👉 What do you think — should pharma focus more on automation, eco-friendly solutions, or digital innovation in the next 5 years?