Our Consulting Service
Extensive experience in the pharmaceutical industry with focus on solid oral DF enables EMOVIAR to offer a consulting service in Drug Product Development and Manufacturing. Our clients benefit from our comprehensive and integrated view on all related aspects of development, regulatory affairs, manufacturing and quality. We present a "straight forward", conclusive solution rather than raising additional questions beyond the specified task.
Drug Product Development
Drug Product Design & Development Plan / Review
Our definition of a superior Drug Product Design:
- Enhancement of API properties => best effective drug product
- Convenient & patient friendly
- Sufficient innovative to enable IP protection
- Robust & reproducible manufacturing & packaging
- Stable formulation; straight forward QC & no QA issues
Sounds like a SWISS ARMY KNIFE?
Our widespread experience in development, RA, QC/QA & manufacturing enables us to offer a Development Strategy Review with the intention to identify potential pitfalls at the time of project initiation - rather than relying on trouble shooting capabilities after product filing and launch.
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Quality / Compliance
Trouble Shooting & Root Cause Analysis
In regulated industries like pharma Trouble Shooting is a "nightmare". A problem needs to be solved under time pressure but actions still need to be compliant with GMP and filed product documentation. Based on focused but bias-free data analysis and a comprehensive understanding of the GMP- "do's" and don'ts" EMOVIAR is able to guide trouble shooting activities with meaningful analytical and technical Investigations.
In FDA 483 Root Cause Analysis is frequently criticized as superficial and non comprehensive. Analytical skills and a widespread view on related disciplines enables EMOVIAR to conduct a meaningful root cause analysis with a comprehensive and conclusive result.
Manufacturing Facility Design
Design Review combining GMP & Productivity
A NICE Manufacturing Facility Design is not necessarily a GOOD design. Design qualification checks against URS are the right way to a BETTER design.
A Design Review conducted by EMOVIAR emphasizes on Combining GMP and Productivity rather than dealing with its contradictions. The result will be regarded as innovative and OUTSTANDING.
Drug Product Manufacturing
Process Optimization & Digitalization
Pharmaceutical Drug Product Manufacturing processes must be robust and validated to ensure a consistent and pre-defined quality of the drug product. This is documented in the filed drug product specification - finally THE link to the pivotal clinical trial formulation on which the drug product demonstrated its performance. Any change of the manufacturing of the drug product has to be treated carefully and is considered as major and complex exercise.
EMOVIAR is able to identify opportunities as well as GMP and regulatory consequences of Process Optimization and / or Digitalization. Our service will provide a Change Control Road Map including economic impact with the overall goal to maintain a compliant pharmaceutical product.
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