Consulting Services

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 consult...

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.

Do you have lots of products and/or products' data which you cannot organize/archive internally...

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 automated...

We provide scale up and optimization strategy. Scale up is based on experimental small scale data (by Designed experiments) and fed into our simulation system.We use physics and chemistry based modeling in our simulations (no black boxing).
Get the digital twin of your process!
Results are clear control...

Rephine’s commissioned audit service gives our customers the opportunity to work with us to design exclusive audits tailored to the specifics of their operations. Customers can commission various audits including:

-API Manufacture-Excipient Manufacture
-Investigational Medicinal Product (IMP) Manu...

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 fo...

IN HOUSE TECHNICAL STRENGTH CONCEPTUAL-BASIC-DETAIL DESIGN ERECTION-COMMISSIONING-VALIDATION COMPLIANCE-BMS 21 CFR PART 11
AHU –DH UPTO 35% EFFECTIVE LATENT COOLING HIGH ENERGY PERFORMANCE LOW CAPITAL INVESTMENT
CHILLER            COOLING ...

Finding a right source meeting your desired specs, compliance, expectations and commercial viability is a challenge. PharmSol, with its global reach, is able to facilitate provision of validated and long term sustainable sources.  •APIs, KSMs  •Finished / Semi Finished Formulations ...

GMP-Support: Qualification / Validation / Consulting 
GMP-consulting and training aligned to your daily work. 

Explicat Pharma GmbH offers consulting and advisory services for gmp, risk analysis, new product development strategypharmaceutical services. Contact us for more information.

Due to recent regulatory developments concerning raw materials, suppliers, manufacturing and distribution, auditing has become a task of critical importance for Life Science businesses.PQE Group supports Pharma and MD companies in performing many types of certified audits, from routine monitoring to due dilig...

Metina supports pharmaceutical company in developing required dosage forms at accredited formulation development laboratory, in line with EU / US reference product. Post development, the product technology would be transferred to suggested manufacturing location.  Metina can also ...

No matter what your Query, we have the answer for you: Market Research Activities, Single Client Studies, Guage Market Potential, Define Entry Strategy, Identify Partners. Services rendered to clients in Korea, Japan, Singapore, Germany, Switzerland and UK.

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 reference ...

OP Pharma has been providing innovative 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 covers the lifecycle management of pharmaceutical products, whole or in part, ranging from digitization of ...

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 DM...

Rephine provides a high-quality service in a timely and cost effective manner, from a single advisory activity to full GCP audits, or Quality Management programme and training. Rephine provides tailor-made solutions that meet the unique needs of your organisation.
Rephine’s portfolio of GCP services incl...

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 Plan...

Rephine’s regulatory consultancy provides a complete portfolio of regulatory services to the pharmaceutical industry from clinical trial regulatory support to product life cycle management. Services include but are not limited to full clinical trial application (CTA) support, ful...

With the in-house regulatory expertise and direct presence of PharmSol through its offices in Europe, PharmSol provides an end to end, single window solution to register and market the product in USA, Europe, Australia and Middle East. •Dossier Preparations / Submissions  •Pharmacovigilance ...