Analytical Development

At Aenova, we provide comprehensive analytical development services to support pharmaceutical and biopharmaceutical products from early-stage through to commercial production.
Our global analytical development laboratories specialize in analytical services – including but 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 with precision and efficiency.

Comprehensive Analytical Development Capabilities

We cover a wide spectrum of pharmaceutical analytical development services for the highest levels of quality and reliability.

Product Types We Support

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:
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, ampoules, and prefilled syringes
We tailor our analytical development strategies and leverage internal expertise experts 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

Our Technologies

Stability Testing & Forced Degradation Studies

Stability testing is crucial for determining a drug product’s shelf life and ensuring long-term efficacy. Aenova provides 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 Choose 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

Additional Development & Technology Services

At Aenova, we provide a wide range of development and technology services for pharmaceutical companies.

Drug Product Development

Clinical Trial Supply Management

Regulatory Support

Technology Transfer

Contact Us

Ready to partner with us for industry-leading analytical development services of the highest standards of safety, efficacy, and compliance?
Contact us today to see speak to our team of experts for support and consultation.

Contact us