Analytical services

Services

How Can We Help?

At Alpine Pharma, we recognize that analytical development is a cornerstone of ensuring product quality, safety, and regulatory compliance throughout the pharmaceutical lifecycle. Our comprehensive analytical services support every phase—from early-stage development through to commercial manufacturing—delivering precise, validated, and regulatory-aligned solutions.

We specialize in the detection and control of critical impurities, including Nitrosamines, heavy metals, and residual solvents, in accordance with global pharmacopeia standards.

Physical & Chemical Testing

Our laboratories are equipped with advanced instrumentation for accurate and reproducible testing, including:

Each method is developed and validated in compliance with international regulatory guidelines to ensure consistent and reliable data.

Stability Studies

Our stability testing programs are designed to evaluate the shelf life and performance of drug products under various environmental conditions. Conducted in line with ICH guidelines, these studies help ensure that your pharmaceutical products maintain potency, safety, and efficacy throughout their intended lifecycle.

Dissolution Testing

Alpine Pharma’s dissolution testing services verify that drug products consistently meet release specifications, quality parameters, and regulatory expectations at every stage of manufacturing and distribution.

Pre-Formulation Studies

We offer detailed pre-formulation studies to support the rational design and development of robust drug formulations. Our scientists thoroughly analyze the physicochemical and biopharmaceutical properties of active pharmaceutical ingredients (APIs), laying the groundwork for efficient, risk-mitigated formulation development.

These early insights help streamline development timelines, improve formulation outcomes, and increase the chances of regulatory approval.

Analytical Method Development & Transfer

At Alpine Pharma, we provide end-to-end analytical method development and method transfer services designed to support efficient product development and regulatory compliance. Our team specializes in crafting robust, reproducible, and validated analytical methods customized to the specific requirements of both active pharmaceutical ingredients (APIs) and finished dosage forms.

With a strong focus on scientific accuracy, regulatory standards, and client-specific needs, we ensure seamless method development and smooth technology transfers across development and manufacturing stages—enabling faster time to market and successful regulatory submissions.

Innovator Characterization & Reverse Engineering

Our innovator characterization and reverse engineering studies play a strategic role in generic drug development and competitive product analysis. These in-depth investigations are designed to dissect the critical quality attributes (CQAs) of branded products or reference listed drugs (RLDs), providing a detailed scientific basis for:

Developing bioequivalent generic formulations

Enhancing or reformulating existing products

Gaining insights into competitor offerings

We prioritize confidentiality, regulatory alignment, and accurate data interpretation, ensuring meaningful outcomes that accelerate formulation design and regulatory approval.

Pharmaceutical Equivalence & Multimedia Dissolution Studies

Our CRO team delivers scientifically rigorous, regulatory-compliant reports that provide clear evidence of product sameness and performance, streamlining your development and approval process.

Alpine Pharma offers pharmaceutical equivalence studies and multimedia dissolution testing to support the comparative evaluation and regulatory acceptance of generic and reformulated drugs. These tests are vital for: