Consulting Services

As part of its commitment to full service support, Avéma Contract Services is pleased to offer our customers support with ANDA and NDA applications, including bio equivalency studies, collecting background data, supervising technology tranfers and reviewing applications to make sure that companies com...

The compliance environment of the pharmaceutical and life science industry can offer very complex challenges. One issue is optimizing workplace technologies in the areas of Business Process Changes, Validation, and general GxP Compliance. At the same time, these challenges must be balanced with the develop...

Quality and compliance solutions delivered by industry-leading specialists

Our experts provide critical GxP-based consulting services throughout the product lifecycle to help our clients successfully bring products to market and maintai...

PharmSol carries out a complete chain of audits which assures product safety and quality to clients across the globe for Finished Products, APIs, Intermediates and Key Starting Materials (KSMs). PharmSol has an in-house team of Auditors who are accredited with various certifications including APIC/CEFIC/AS...

Our goal is to improve your pharmaceutical R&D through knowledge management: Explicat®`s expertise in the planning, design, execution and delivery of drug development programs results in customized development solutions.

Those are designed to lead to early proof of concept, effic...

QEdge is an enterprise-wide Risk based, Quality management Software to ensure product Quality and regulatory compliance, and Audit Readiness.

·QEdge eQMS has configured 60 + Process

Data Integrity Part 11 (21 CFR Part 11, Annex 11) compliant Risk ...

Our team of experts will prepare necessary protocols incorporating all critical parameters


Process Validation:

PharmEng professionals possess experience in validating pharmaceutical and biopharmaceutical manufacturing processes. Our team of experts will prepare necessary protocols i...

We have professional translators that can provide: - English & Chinese interpretation services during international GMP audits; - English & Chinese interpretation services during communication with NMPA and other authorities; - English & Chinese translation of audit reports / CAPA reports; - En...

Is the enzyme you are interested in not commercially available and a production needs to be developed? Enzymicals has extensive expertise with scale-up from lab to pilot-scale and technology transfers to industrial manufacturing sites. We can supply your protein by in-house production up to the kg-scale...

We offer research and development services at all stages of the production of capsules, from idea to finished product for medicinal products, medical devices, food supplements, cosmetics and veterinary products.

We offer our clients a proper identification of their needs and requirements, r...

Rephine provides personalised, detailed and comprehensive GMP audit reports that are recognised and accepted by QPs and regulatory authorities around the world. The Rephine list of audit reports is updated regularly.

If the audit you require is not on the list, you can review the Rephine Audit P...

Condair Esco is a pure steam humidifier which injects plant supplied pure steam through 100% leak-proof stainless steel control valve with stainless steel steam distributors. Condensate is continuously drained from the steam distributors to prevent microbial contamination in the air stream.

• Quality Systems Development • Data Integrity • Quality IT Systems • Quality Remediation • Management Controls • Risk Management • Design Controls • Project Management • Train and Qualify Staff

Consulting services which create value by combining our expert scientific background with highly qualified staff, equipments and facilities, to deliver advanced particle characterization studies such as:

- Development validation and transfer of analytical methods

- Comparative...

Catalyst characterisation based on an extensive knowledge base and experience, will determine a tailored treatment process, which will deliver the best value returns. Understanding your process where the catalyst is utilised will help determine the treatment route and matrix effects, such as the residual ...

MEDIPHA SANTE offers Quality Assurance services which include : 
Management of quality system documentation
Management of quality topics  (Complaints, Change Controls , Deviations  CAPAs, Training, Product Quality Review, Quality Indicator, Quality meeting, Risk analysis...

OP Pharma has been providing all-around services in the Regulatory Affairs field for more than 20 years to small to big pharma Companies in Italy as well as in the European Union.
Our expertise ranges from submission of registrations, variations, prices, texts, renewals (also via CESP), to CEP and...

We provide a Custom Protein Synthesis Service, using a chemical method that synthesises proteins amino acid by amino acid and making modifications on an atomic-scale. We work closely with our partners in designing, customising and optimising the proteins that is synthesized in an automa...

Data is a fundamental part of any Life Science production cycle and has become a major concern for global regulatory authorities.Choose PQE and ensure patient safety and business continuity within the entire product life cycle.

Metina has efficiently managed multiple ANDA's submissions and approvals. Metina provides assistance starting from regulatory advice during product development, controlled correspondence with FDA, writing of scientific dossier in CTD, conversion into eCTD, online submission support to USFDA, query response...