ALPI Solutions

02/19/2026

Field Force 2026: reps don’t disappear. They evolve.

Pharma used to measure success by one thing:
“How many visits did we make this week?” But that model is changing.
Today it’s about:

• smarter targeting
• data before territory
• hybrid meetings (digital + in-person)
• real clinical conversations instead of product monologues

Doctors are overloaded.
Time is limited.
Data matters more than repetition.

The strongest field teams in 2026 aren’t the busiest.
They’re the most precise.
Pharma is moving from “more visits” to “better impact.”
And that shift is permanent.

02/12/2026

ALPI Solutions at MD&M West 2026 | Key Takeaways
Last week, the ALPI Solutions team attended MD&M West 2026 in Anaheim, one of the most important industry exhibitions at the intersection of medical devices, manufacturing, and regulatory affairs.
For us, MD&M is not just about technologies — it’s about understanding how regulatory expectations translate into real devices, real manufacturing processes, and real compliance decisions.
What stood out most:
• Regulatory Affairs is becoming a strategic function, deeply integrated into design, materials, and manufacturing
• Strong focus on traceability, data integrity, design controls, and lifecycle compliance
• Increasing complexity of medical devices and multi-vendor supply chains, raising new regulatory challenges
• Practical, experience-based sessions discussing real inspection findings and compliance pitfalls
• A strong and visible role of women professionals in MedTech, regulatory, engineering, and leadership positions
Events like MD&M West reinforce the importance of early regulatory involvement, cross-functional collaboration, and continuous learning in today’s MedTech environment.
We’re bringing these insights back into our work to support smarter regulatory strategies and sustainable compliance for medical and healthcare projects.

02/10/2026

Why the Biostatistics Symposium of Southern California (BSSC) Matters
The Alpi Solutions team recently attended the Biostatistics Symposium of Southern California (BSSC) — a serious scientific and applied forum focused on how modern biopharma actually works.
Key topics included:
✔ clinical trial design and statistics
✔ adaptive and Bayesian approaches
✔ oncology studies and real-world evidence
✔ AI and data science in clinical research
This was not about trends or buzzwords.
It was about how decisions made at the design and data level directly affect regulatory outcomes and patient impact.
At Alpi Solutions, we work exactly at this intersection — where science, statistics, and regulatory strategy come together.
📖 We’ve published a detailed breakdown of BSSC insights on Medium — link in comments.

01/15/2026

Biotech layoffs: what’s really happening?

According to the BioSpace Layoff Tracker, many biopharma companies and biotech startups are reducing staff in 2026 to cut costs and rethink their growth strategies.

This is more than a hiring issue — it’s a sign that companies need to streamline operations, focus their R&D pipelines, and build smarter, more efficient regulatory strategies to move forward in a tougher market.

In times like these, clarity and ex*****on matter more than scale.

Follow along as BioSpace tracks job cuts and restructuring initiatives.

01/08/2026

Pharma Outlook 2026: what will shape Pharma & Biotech this year

2026 is a year of strategic choices for pharma and biotech — not just scientific breakthroughs.

Here are a few key forces already shaping the industry:

🔹 Pricing pressure is becoming the new normal
Global cost-containment policies are pushing companies to clearly demonstrate value — earlier and more thoughtfully.

🔹 Real-world evidence matters more than ever
RWE is now a key part of market access, payer discussions, and long-term product strategy.

🔹 AI in market research: helpful tool, not a magic solution
AI can speed up analysis, but it still needs expert interpretation and context.

🔹 Faster regulatory pathways don’t mean simpler requirements
Acceleration still comes with higher expectations for evidence and planning.

The companies that succeed in 2026 will be those that think ahead and plan early.

At ALPI Solutions, we support pharma and biotech teams in navigating these shifts — from early insight to strategic ex*****on.

💬 Which of these trends do you see impacting your work the most in 2026?

12/23/2025

2025 Year in Review

2025 for ALPI Solutions: a year of meaningful work and true partnership

The end of the year is always a moment to pause and look back honestly.
For ALPI Solutions, 2025 became a year when one thing stood out with particular clarity — the value of long-term, professional partnerships.

What we accomplished in 2025

🔹 Regulatory Affairs & FAERS
We supported pharmaceutical companies in navigating complex safety, regulatory, and pharmacovigilance challenges — calmly, systematically, and without unnecessary noise, always focusing on meaningful results.

🔹 Market Research
We conducted in-depth market research, helping our clients better understand:
• the market,
• competitors,
• real growth opportunities and risks.

🔹 Field Force Strategy
We worked closely with commercial teams to build more precise, thoughtful, and effective field operations — driven by data rather than assumptions.

This year was also important because
• we participated in professional events and industry conferences,
• continuously strengthened our expertise,
• reinforced our approach to quality, structure, and responsibility.

But most importantly, we worked side by side with our clients, supporting them in making complex decisions in an increasingly challenging pharmaceutical landscape.

Looking ahead to 2026

We sincerely wish that 2026 brings you:
• achieved goals and realized plans,
• sustainable growth and confidence in the future,
• partnerships that deliver not only results, but also genuine satisfaction.

May collaboration bring professional, emotional, and financial fulfillment.

True partnership is when results matter more than words, and trust is more valuable than quick wins.

Thank you for being with us in 2025.
With appreciation and respect,
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.