Analytical Solutions for Pharmaceutical Drug Development

Analytical Testing Solutions That Accelerate Pharmaceutical Development

We provide comprehensive analytical development services to support pharmaceutical and biopharmaceutical products from early-stage through to commercial production.

Each of our Centers of Excellence for Development is supported by a specialized analytical development team.

Our global analytical development laboratories offer targeted analytical development to support optimal control of raw materials, product quality (identity, strength and purity) and consistent process performance (in-process controls) for a wide range of products and processes. Our services include - but are not limited to - method development, validation, stability testing and raw material analysis, with extensive experience in ICH stability testing, analytical method transfer, impurity profiling, and cleaning validation, we help pharmaceutical companies not only meet but surpass regulatory standards.

Comprehensive Analytical Development Capabilities

Our analytical development teams support your project from initial development trials to process validation in full compliance to cGMP requirements. All common pharmacopoeial chemical, physical or biological methods are established either through our extensive in-house analytical capabilities or, if required, through a broad network of qualified contract laboratories.

Our analytical development teams work closely with our internal teams to support a wide range of pharmaceutical product types to support drug products in the following formats.

Product Types We Support

Solids: Tablets, capsules, and granules

Soft Gel Capsules: Advanced gelatin-based formulations for improved bioavailability

Semisolids & Liquids: Creams, gels, ointments, suspensions, and syrups

Sterile Injectables: Parenteral drug products, including vials and prefilled syringes

We tailor our analytical development strategies and leverage internal expertise to ensure optimal performance and compliance across a wide range of drug products.

Analytical Method Development & Validation

Through robust analytical method development strategies, we ensure accuracy, precision, and reliability of pharmaceutical testing, in which our analytical scientists, develop, validate and perform testing for analytical methods.

We follow ICH, FDA, and GMP guidelines to ensure compliance while using advanced analytical techniques such as HPLC, mass spectrometry, and chromatography. Our expertise includes:

Development of analytical methods for pharmaceuticals to assess identity, purity, and potency
Analytical method validation and transfer to support regulatory approvals
Analytical development for formulation and manufacturing optimization

Technologies

Our modern laboratories are equipped with a wide range of analytical instruments, such as HPLC, residual solvents determination (GC), residual water determination (Karl Fischer), thin layer chromatography (TLC) and dissolution testing.

Besides standard techniques, we can perform specialized analytics for raw material characterization or attribute testing that is specific for individual dosage forms:

Material characterization

Morphological evaluation (e.g. digital morphological evaluation or laser light diffraction)

Specialized technologies by dosage form

Solids: characterization of particle size
Liquids: suspension settling tests
Sterile products: microbiological testing in house
Semisolids: permeability testing

Stability Testing & Forced Degradation Studies

Stability testing is crucial for determining a drug product’s shelf life and ensuring long-term efficacy. At Aenova, we provide ICH and pharmacopoeial compliant stability studies under a range of environmental conditions, including accelerated, intermediate, and long-term testing.

We also offer forced degradation studies to assess the degradation pathways of active pharmaceutical ingredients (APIs) and finished products. Our studies follow FDA and ICH guidelines and include:

Forced degradation analysis by HPLC and mass spectrometry
ICH stability studies for regulatory submissions
Stability testing of biotechnological and biological products

Raw Material Testing & Impurity Profiling

Ensuring the quality of raw materials is essential for pharmaceutical manufacturing. Our raw material testing laboratories analyze active ingredients, excipients, and packaging components for compliance with regulatory standards.

We use USP, Ph. Eur., and FDA-approved methods to detect contaminants, degradation products, and impurities. Our services include:

Raw material testing in pharmaceuticals to verify identity, purity, and consistency
Pharmaceutical impurity testing to ensure compliance with regulatory thresholds
Sampling and testing of raw materials under GMP guidelines

Cleaning Validation & Analytical Method Transfer

Cleaning validation ensures that pharmaceutical manufacturing equipment is free from residual contaminants. Our cleaning validation services comply with FDA, EMA, and GMP requirements, ensuring patient safety and regulatory approval.

We also provide analytical method transfer and validation, helping companies transition analytical methods between laboratories and manufacturing sites while maintaining consistency. Our expertise includes:

Analytical method validation for cleaning validation in pharmaceutical and medical device industries
Cleaning validation protocols for dedicated and multi-use equipment
Method transfer validation to maintain analytical accuracy across facilities

Why Rely on Aenova for Analytical Development?

Aenova is a global leader in pharmaceutical analytical development, offering:

Regulatory expertise in ICH, FDA, and GMP compliance
State-of-the-art analytical laboratories with cutting-edge instrumentation
End-to-end analytical services, from method development to stability testing
Customized solutions for small molecules, biologics, and medical devices
A passionate team that, together with you, goes the extra mile to bring drugs to patients quickly and safely