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

Solve complex regulatory
queries - Augment

 

What is Augment

Resolving all the BE related questions which are unanswered and beyond the scope of CRO!

Bioequivalence feasibility to submit query response of a generic product is a long process. As you invest a fortune in the product development it is best not to leave any loose ends. At times you may not have the expertise to perform certain functions due to its complexity, so why not take help from someone who has been doing it for decades. You focus on your core areas and leave those challenges to us. We have an edge in most of the activities related to bioequivalence as we have nurtured a team with very specific expertise.   Through years of experience and number of projects we have managed to build robust systems and in depth understanding of the bioequivalence.   This allows us to identify the challenges and provide possible solutions with ease. The exposure we with most of the advanced regulatory authorities in the world makes us well equipped to face critical queries in the appropriate manner.    

Solution

Solution

"AUGMENT" is a very flexible service which provides the option of utilizing the expertise of Pharmadesk for very specific requirements. The spread of the solutions provided by Pharmadesk covers post bioequivalence study challenges like root cause analysis, Bio-waiver query response and controlled correspondence with the regulatory authorities.   Augment; as the name suggests, it is all about adding values. Whenever there is a situation where you are not sure about the solution or you want to seek a second opinion, we pitch in. During the BE study you may come across multiple challenges where you simply need a well-researched opinion backed by years of experience. It might be just a quick confirmation of the strategy you have already decided or a simple query response which needs a lot of research. Pharmadesk provides solution to all the ancillary challenges you face during the BE study through Augment.

Augment Features

Augment

Provides solution to following challenges

Business Challenges
Challenges 1

Can we establish effective IVIVC and skip pilot study?

Challenges 2

In case of a fasting and fed study which study do we need to perform first?

Challenges 3

Can we use Two Stage or Add on Design instead of repeating study on higher sample size?

Other Challenges

Compare Services

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