Consulting Services

Finding a right source meeting your desired specifications, compliance, expectations and commercial viability is a challenge.

Project resource management includes forecasting the need to hire and/or outsource some tasks. When projects are high-value and require strategic decisions, in-house resources may be insufficient. Similarly, administrative action items are better left to contract workers so as to not overburden your staff....

We specialize in IA and non-AI Computer System Validation, equipment validation, utilities qualification, and IT/OT infrastructure qualification. Our services comply with the regulatory standards of the EMA, FDA, WHO, and other key Life Science authorities across Europe and the Americas. With a proven trac...

PeP11 LabCal offers a Single Validation SaaS Solution Platform that manages all Excel spreadsheets, eliminating the need for individual validations. This comprehensive electronic Excel solution features an Electronic Signature, Audit Trail, and Role-Based Access, rendering paper signatures unnecessary ...

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...

AUDITING: - Support its clients on Vendor Audit; COMMISSIONING:- Manages and performs commissioning activities for new systems, equipments and facilities; 
TESTING:- Performs the following testing activities using its own instrumentation saving costs and time on tests planning; 
COMP...

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...

Intertek design audit and action plans to meet the requirements of pharmaceutical clients to ensure compliance with EC standards, FDA regulations and WHO concerns. During a pharmaceutical audit process, Intertek takes a "snapshot" of the company's existing quality system, and superimposes it on the referen...

Avivia offers full product development services to generic drug companies and specialty pharma focused on the development of new improved versions (value-added generics or generic plus) of established drug products.
Although in general the overall aim of value-added generic development projects is focu...

Our Drug Development Consultants work with you to design and implement successful drug development programs. With industry leading scientific expertise across a range of technical disciplines, we help customers across all stages of development, from candidate selection to commercial launch.

Our cons...

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...

KLINEA is a company fully committed to providing added value solutions for the life sciences industry, specialized in Engineering Services, Project Management and Quality Scrutineering Tests, with offices in Madrid and Barcelona. Founded by a highly qualified technical team with more than 15 years of e...

MFT Consult, our team combines deep expertise in regulatory compliance, facility design, QMS, and technology transfer with the ability to act quickly and efficiently. With decades of experience in the pharmaceutical and biopharmaceutical industries. we specialize in guiding startups in the pharmaceutical a...

ArabMed CRO is renowned for its expertise in conducting clinical trials across all phases, from Phase I to Phase IV, with a strong track record in drug research. The company also excels in medical device clinical investigations, demonstrating its commitment to advancing medical technologies. With a focus o...

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...

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...

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...

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 provide comprehensive support for the ARD and F&D Site GMP verification, API and FDF manufacturing Site GMP verification, BE and clinical site GCP verification and GLP verification audits. We extend the support to the storage facilities also.