Qualified & highly experience
bioequivalence service desk that work as your local expert

Plan & execute your Biostudy
- Synonym

 

What is Synonym

Several factors determine bio-success. Planning of a study is a holistic approach. This planning doesn't start from study designing but right from the API / formulation development strategies and approaches. A due care in planning and strategizing is required from the beginning to the conclusion of the study. Experts from different areas require to review and analyse the data from time to time to ensure progress of the formulation development is in the right direction.   To overcome all these hurdles, complete care of your biostudy from CRO selection to pre-study activities to execution, monitoring, project management, regulatory submission to handling of regulatory queries will be taken by Pharmadesk. We have a complete package for bioequivalence where you need not have to look / track any activity of biostudy by yourself. You can just sit back and relax where our efficient and trained team will complete all the tasks and activities on behalf of you. Remember we considered this as our project, so it's our responsibility to complete our project in defined timeline and with the help of allotted resources.

Solution

Solution

Synonym is a service through which we cover the complete BE study cycle for your product. We support the sponsor of the BE study from product feasibility studies to final report compilation. With a strong network of CROs and in-house quality assessment team, we also scout the right CRO as per the need of the BE study. With a proven track record and technical knowhow, we provide BE study monitoring and complete analysis of the BE results. After working closely with USFDA, MHRA, TGA, Health Canada and other regulatory agencies we provide appropriate responses to the queries faced by the sponsors.   Through Synonym we bring to you a cumulative knowledge and exposure of 380 successful BE studies and more importantly peace of mind.   Synonym is well designed service which provides an integrated solution for the challenges faced by Pharmaceutical companies in overall BE study management. After years of exposure to the complicated activities of Bioequivalence and facing most of the regulatory authorities in this regard we precisely know the right way to do it. Hence, through Synonym we offer the perfect scientific understanding for your product to get introduced to the human system for the first time and sail through this critical & important phase of product life cycle.

Synonym Features

Synonym

Provides solution to following challenges

Business Challenges
Challenges 1

We wish to have expert team who can handle BE studies to ensure zero regulatory finding & hassle free approval?

Other Challenges

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Services Bio vigil On track Augment Synonym
PRE STUDY
Product Feasibility
Site identification & Qualification      
Regulatory approval/BE NOC & T License      
CLINICAL PHASE
Protocol Design or Review    
Sample Size estimation or Approval  
Statistical Design or Approval  
CRF, ICF, ECG, CSR Review    
Study Monitoring & Study Compliance    
Study Monitoring observations & reporting    
BIOANALYTICAL PHASE
MD MV & Analytical data Review    
STATISTICAL PHASE
Statistical & PK report review & Data Interpretation    
Root cause analysis    
TRACKING OF PROJECT
TRACKING OF PROJECT      
REGULATORY
Scientific Advisory Meeting    
Biowaiver & other Regulatory Query Response    
Controlled Correspondence with Regulatory Authority