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  • Biopharmaceutics &
    Project Management Services
BPD TEAM

Biopharmaceutics

For biopharmaceutics services in India Veeda is the best partner of choice as Veeda Clinical Research has an impeccable experience as a team experienced with over 2000+ Clinical studies ranging from BA/BE to Human Pharmacology Studies. Combined experience of all the senior personnel is more than 100 man working years in Pharmaceutical companies and CROs put together.

With such an in depth technical and regulatory insight, we are providing this new specialty service as a part of our value-added service offering to our clients to work with them in the generic drug development process. We differentiate ourselves by adding depth and breadth to our services which would result in a higher success rate in BA/BE studies and speed to market for our sponsors.

Considering the overall diversity in service offerings as a Knowledge based CRO, Veeda now offers a fortified basket of offerings in the areas of:
  • Feasibility Assessment of conventional as well as novel molecule/formulation (including scientific/technical inputs from Regulatory compliance perspective)
  • Study Design
  • Different dosage forms (Inhalation, Transdermal, etc)
  • Medical Writing
  • Report Writing
  • Statistical Concepts
  • Data Interpretation and Evaluation
  • Regulatory Aspects

Through this service, we can provide strategized solutions in generic drug development process by providing better alternatives / approaches. Moreover, we have also initiated providing support on in vitro release related interpretation and correlation with in vivo results.

Capabilities:

  • Conducted more than 3500 Feasibility assessment
  • Scientific and regulatory compliant protocol designing for different dosage formulations such as Solids, Injectable, semisolid, Respiratory drug delivery system, Insulin analogs, Derma products
  • Successful management around 390 studies healthy subjects in the past 1.25 years including 20 special studies in different segments (i.e. Transdermal patch, inhalation, Rectal suppository, Injectable at hospital site)
  • Established FDA required CDISC procedure and successfully completed CDISC for more than 150 studies with difference design.
  • Established mechanism of 2 project reports per calendar day (433 draft reports and 422 final reports)
  • Maintained Good track record to get regulatory (CDSCO) approval in time. For NOC+TL: average 35 calendar days (156 approvals), for only TL: average 9 calendar days (172 approvals)
  • Meticulous planning and execution of 22 pivotal bio studies to support 10 ANDA applications (including FTF and NCE-1) wherein final reports were delivered within few days of analysis completion.
  • Vast experience in Protocol preparation, project management, report writing, PK and stat analysis Biosimilar studies in India (i.e. Insulin and GCSF studies).

Project Management Services

Veeda has a highly competent Project Management team who managed complex projects with great finesse and accuracy. Our Project Management Group oversees the entire project flow right from the stage of first Client Interaction till final report dispatch to the client. We also offer post-submission query resolution support till product approval from the Regulatory authorities.


Veeda offers the concept of Client-specific Project Managers, increasing the ease of communication. The stability of our Project Management team is exceptional with < 10% attrition in the Project Management team which ensures single-point contact for the clients. With all the mentioned attributes, Veeda offers Project Management services to the Clients who wish to have a world-class scientific Project Manager managing their projects.


  • Scientists having hands-on experience become Project Managers
  • All the Project Managers are either Post-graduates and / or pursuing Doctorate studies, by education.
  • Have in-depth understanding of study designs, statistical concepts, reporting requirements, regulatory aspects and Business nuances.
  • Exceptional communication skills with Openness and transparency.
  • Personable and committed to clients.

WHY VEEDA?

  • Veeda is an Independent CRO with 14 years of experience.
  • Veeda has conducted over 2500+ studies for USFDA/MHRA/EU
  • Vast experience in Scientific and regulatory compliant protocol designing for different dosage formulations.
  • Veeda has worked with over 200 pharmaceutical companies around the world ,and has Master Service Agreements with many of the top global pharmaceutical companies
  • Veeda has been audited 18 times in last 21 months and has had no 483
  • Quality is part of our DNA.
  • Good track record to get regulatory (CDSCO) approval in time
  • Experienced team to handle the criticalities and challenges with thorough feasibility assessment Scalable team approach
  • Vast experience in Protocol preparation, project management services, report writing, PK and stat analysis for regular as well as complex
  • studies (Biosimilars & studies for different type of dosage forms)

Our exemplary regulatory track record

USFDA
33 times
Brazil ANVISA
7 times
WHO
5 times
UK MHRA
3 times
EU - AGES
1 times
South Africa - MCC
1 times
NPRA - Malaysia
4 times
DCGI
13 times