Contract Development

EVER is a leader in pharmaceutical development, guiding clients through the complex process to ensure safety and efficiency at every stage. We collaborate closely with your team to meet your milestones and successfully bring your product to the market.

Our end-to-end service covers every aspect of pharmaceutical development, from API selection to final process validation and quality assurance, with the highest level of expertise.

With state-of-the-art labs in Unterach (Austria), and Jena (Germany), EVER ensures that projects are developed under optimal conditions with access to specialized equipment and expertise at each critical phase of development.

Development Services

Sterile Fill-Finish Pharmaceutical Development

Our sterile fill-finish service can handle any challenge, from solubility and stability issues to complex formulations. We have a track record of developing and approving parenteral products such as low oxygen formulations, crystal suspensions and oily solutions, including highly active substances like hormones and cytotoxics (up to OEL class 5).

With over 40 years of experience, we provide integrated solutions for both clinical and commercial projects, ensuring the successful delivery of life-changing therapies.

Formulating Potent and Non-Potent Drugs

We offer a comprehensive service for new drug development, early stage formulation, and analytical development of potent and non-potent drug products. With our 35-year expertise in processing various dosage forms, such as liquids, solutions, suspensions and emulsions, we can partner with you from pre-clinical API characterization to full commercial launch.

Services overview

API Screening and Selection	Finding the best active pharmaceutical ingredients (APIs) for your product development.
Analytical Method Development	Designing robust analytical methods based on Analytical Quality by Design (AQbD) to ensure product quality and consistency. Read more
Analytical Method Validation	Confirming the accuracy, precision, and reliability of analytical methods according to ICH Q2(R2).
	Extractables and Leachables (E&L) testing (inhouse) considering USP and EMA requirements including preparation of risk assessments for submission.
Formulation Screening and Selection	Exploring and evaluating various formulations to choose the most effective and viable options.
Formulation Development	Developing formulations in compliance with ICH guidelines to ensure safety, efficacy, and quality.
Scale-Up and Transfer into Production	Scaling up the manufacturing process and transferring it to EVER’s production facility in Jena.
Process Validation	Validating manufacturing processes to ensure they consistently produce products meeting predetermined quality criteria.
Package Material Selection	Selecting appropriate packaging materials to maintain product stability and integrity.
Stability Testing	Conducting stability studies under various ICH-recommended conditions to determine product shelf life and storage requirements. Read more
Filter Membrane Testing and Selection	Testing and choosing suitable filter membranes to ensure sufficient flow waters while maintaining product purity and safety.
Scale-Up and Transfer into Production	Scaling up the manufacturing process and transferring it to EVER’s production facility in Jena.
Container Closure Integrity Testing (CCIT)	Testing to ensure that containers maintain their integrity and protect the product from contamination.
On-Site QA Oversight and Documentation	Providing QA oversight and maintaining thorough documentation in English to ensure transparency and compliance with regulatory standards.
Special Instruments and Analytical Methodologies

100+
developers

9 Official
certifications

Crystalline suspensions

Hormones

Analytics

Analytical Method Development

We offer GMP analytical testing, simplifying your supply chain and accelerating your timelines. We can develop new methods in-house or transfer existing validated methods to meet your product specifications.

We follow ICH validation guidelines for all analytical methods, supporting development, in-process, release, and stability testing.

We have the latest instrumentation to meet your testing requirements and we constantly update and expand our testing capabilities to match your needs. We excel in analytical method development. Whether you need a new method or an optimization of an existing one, we can provide accurate and reliable results throughout the product lifecycle and deliver GMP-compliant documents for regulatory filing.

Analytical Testing

SDS-PAGE

Appearance, pH, Osmolality, Density, Reconstitution Time, and Extractable Volume

HPLC with DAD and MS detectors

Testing for substances that could leach from packaging or processing materials into the product.

Nitrosamine Testing (partially external)

Assessing and mitigating risks related to elemental impurities and nitrosamines as per European Union regulations.

Ion chromatography

LC/MS/MS and high-res MS (coming in 2025) for structure elucidation and E&L studies

GC/FID and GC/MS for residual solvents and E&L testing

FTIR and UV/Vis

Karl Fischer and Oxygen Headspace Analysis

Non-destructive laser measurement of headspace oxygen

Glove box to manipulate the gas phase in vials and syringes

Low oxygen filling of vials and syringes (e.g. down to 0.2% residual oxygen in headspace)

Rotational Viscometer with different shear rates

Sterile wet ball milling for injectable suspensions (fully CIP and SIP-able)

Particle size distribution (Malvern Master Sizer and Zeta Sizer)

Dissolution testing of injectable suspensions (USP apparatuses 2 and 4 with automatic sample collection)

Filter flow apparatus for filter membrane suitability testing and selection

Pilot plant for filling of small-scale batches

Qualification

We validate transferred or in-house developed methods according to phase-appropriate approaches for GMP use, supporting in-process, release, and/or stability testing.

Microbiological Testing Services

Our microbiologists can reduce the amount of API or BDS needed to qualify your microbiological tests.

Bioburden
Endotoxin
Sterility
Container Closure Integrity
Anti-microbial Effectiveness Test (AET)
Preservative Efficacy Test (PET)
Container Closure Integrity incl. bacterial intrusion testing

Stability Testing

We will design a robust and compliant stability program based on ICH guidelines and your product’s specific requirements, minimizing the use of your clinical supply.
We continue to evaluate and expand our testing capabilities to support your growing needs.

We can simplify your supply chain and reduce the risk and cost of cold-chain shipments and transferring your analytical methods to a third-party lab.

Our Stability Testing Services

ICH Stability Conditions

-20°C
2-8°C
25°C/60%RH
30°C/65%RH
40°C/75%RH

ICH Photostability

We can perform non-GMP and GMP photostability studies for drug substance and finished product.
Photostability protocol development following ICH Q1B stability guidelines
Exposing products to validated light sources at the recommended light-intensity.
Time point management, testing, and data reporting with quality oversight
Final report

Protecting your Product

Our stability chambers and facilities are backed by redundant systems to safeguard your valuable drug product throughout the stability program.

Our facilities redundancy includes over-sized backup power generators, a validated building monitoring system with redundant alarms and integrated UPS (uninterruptible power supplies) technology.

Commitment to Quality

Our integrated teams will provide you with personalized attention and streamlined communication throughout your stability study.

We will provide interim reports at each critical milestone of the program to support your regulatory submissions.

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