Pharmadesk through their strong technical support and subject domain expertise have always handled our complex biostudies for all regulated market (EU, US, Canada) efficiently and delivered on time. The team has been a constant support for all our technical queries.
Generic Partners
Pharmadesk has been a great company to work with. They created a personalized service and took the time to understand our business and our projects. We can always trust them to provide the most efficient solutions. With them by our side, we have the confidence to continue growing our business.
Chemo Centroamericana SA
Our experience with Pharmadesk has been really great. The coordination of the projects of bioequivalence studies is really good. The support before, during and after the project its very professional. They have very talented people in their team, that are well trained to give response to any query of the sponsor.
Lab Stein S.A.
Pharmadesk have a professional and scientific base for conducting studies and dealing with all regulatory concerns in an efficient and timely manner.
Kinedexe UK Ltd
Only platform in the world where you can search by molecule name & connect
to all CRO's which has experience on it.
Can we establish effective IVIVC and skip pilot study?
In case of a fasting and fed study which study do we need to perform first?
Can we use Two Stage or Add on Design instead of repeating study on higher sample size?
Can we combine multiple biostudies without risk of rejection for EU submission?
How can we ensure that sample size for biostudy is not higher or under power?
We need assistance in writing controlled correspondence to USFDA or EMEA
We need technical experts for writing Clinical, Nonclinical & Bibliographic review.
How to tackle Data Integrity issue of a CRO ?
How to Qualify CRO for BE studies?
How to investigate a failed biostudy to find out the root cause of its failure?
We wish to have expert team who can handle BE studies to ensure zero regulatory finding & hassle free approval?
How to handle timeline & operational issues for biostudy ?
We need qualified & experience team to monitor our bioequivalence studies.
We will never share your email address and you can opt anytime, we promise.
Medical writing is as standalone service. This includes module writing such as Clinical & Non Clinical overviews, SmPC & its comparison, study labels, patient information sheet, protocols, regulatory communication & controlled.
Pharmadesk offers an unmatched combination of knowledge, project management skills and experience of handling hundreds of bioequivalence studies for various submission all across the world.
Our diverse team of professionals, consultants & subject matter experts help us to evolve new approaches and capabilities to meet new challenges in bioequivalence
Unlike a 'typical' Project Management company, which..
Unlike a 'typical' Project Management company, which merely plan & execute your project, our approach is more 'Consultative..
We take ownership of the project. We involve in and study..
We take ownership of the project. We involve in and study the earlier important stages of the project / development, so as to establish a co-relation..
You, our Customer First. We understand & consider your..
You, our Customer First. We understand & consider your culture, needs of your organisation, your goals & objectives and design our..
25+ qualified team of Project Managers, Clinicians..
25+ qualified team of Project Managers, Clinicians, Pharmacologists, Formulators, Analytical & Bioanalytical experts as well as Ex—MHRA Consultant..
Experts take a holistic approach while formulating strategies..
Experts take a holistic approach while formulating strategies in bioanalytical method selection/ alteration, appropriate sample size determination..
Experts take a holistic approach while formulating strategies ..
Experts take a holistic approach while formulating strategies in bioanalytical method selection/ alteration, appropriate ..
Help in careful drafting of the legal terms & conditions..
Help in careful drafting of the legal terms & conditions / agreements to avoid commercial exploitation in case of any grievances, especially in..
Bridging you & your service provider/s ensuring smooth..
Bridging you & your service provider/s ensuring smooth transactions & communication. We take care of all your local needs..
In depth study & analysis of your past pass / fail study data..
In depth study & analysis of your past pass / fail study data to take course correcting measures for future planned studies. Periodic assessment of activities..
Close monitoring by our subject expert keep a close vigil..
Close monitoring by our subject expert keep a close vigil and can guide CRO at every important stage gate of the project to ensure that the project is on..
We are UKAS, a British Government recognised body, ..
We are UKAS, a British Government recognised body, certified and has been accredited for "Management of BioEquivalence ..
Strong Project Management software engine is driven..
Strong Project Management software engine is driven by strong processes & workflow and validated check list to ensure Quality ..
Dedicated Project Manager, Single point of contact..
Dedicated Project Manager, Single point of contact, online project tracking tool, periodic & scheduled telecons & Complete loyalty towards..
Being local, on your behalf, we can negotiate and get the best..
Being local, on your behalf, we can negotiate and get the best prices for different supplies [ e.g. regulatory service provider, RLD, analytical..
We will get back to you soon.
Unlike a 'typical' Project Management company, which merely plan & execute your project, our approach is more 'Consultative and Solution Oriented'
We take ownership of the project. We involve in and study the earlier important stages of the project / development, so as to establish a co-relation between actual in-vitro and anticipated in-vivo outcomes and accordingly, if required, suggest a course correction.
You, our Customer First. We understand & consider your culture, needs of your organisation, your goals & objectives and design our approach around it. We ensure that the system, practices, processes, we recommend, are aligned with your Organisation’s needs. Customization of strategies / approach anticipating future complexities & problems.
25+ qualified team of Project Managers, Clinicians, Pharmacologists, Formulators, Analytical & Bioanalytical experts as well as Ex—MHRA Consultant on Board make our system full proof yet flexible.
Experts take a holistic approach while formulating strategies in bioanalytical method selection/ alteration, appropriate sample size determination, overall study/ protocol designing, Bio-waiver justification and data interpretation. Thus by designating PharmaDesk you are not hiring Project Managers but Domain Experts.
Have done Qualification audits / have scanned almost all CROs from India. Have done SWOT analysis of CROs, which gives us Power to choose one as per Project’s need. Also we can assess CROs for data integrity to ensure prevention of future possible damages.
Help in careful drafting of the legal terms & conditions / agreements to avoid commercial exploitation in case of any grievances, especially in the cases of data integrity.
Bridging you & your service provider/s ensuring smooth transactions & communication. We take care of all your local needs.
In depth study & analysis of your past pass / fail study data to take course correcting measures for future planned studies. Periodic assessment of activities to check on possible pitfalls / nasty surprises.
Close monitoring by our subject expert keep a close vigil and can guide CRO at every important stage gate of the project to ensure that the project is on track and regulatory compliant.
Off load your worries on our shoulders. We know what you want, what regulators look for and how to get it
done, what is required in a systematic & in timely manner, from the CRO/s.
80+ successful approvals across EU, TGA, US and Canada.
We are UKAS, a British Government recognised body, certified and has been accredited for "Management of
BioEquivalence & BioAvailability, Clinical Development, Scientific & Medical Writing and
Pharmaceutical Development services".
Strong Project Management software engine is driven by strong processes & workflow and validated check list to ensure Quality Compliance & Project is always on track.
Dedicated Project Manager, Single point of contact, online project tracking tool, periodic & scheduled telecons & Complete loyalty towards client makes us a trusted project management partner across the globe by leading Pharma & Biotec companies.
Being local, on your behalf, we can negotiate and get the best prices for different supplies [ e.g. regulatory service provider, RLD, analytical column, standards suppliers etc]. Further, we have long term special pricing ‘rate contracts’ with most of the leading CROs and on the top, no need to identify and deploy any independent monitoring agency..!! So you can save costs at different stages of project on different fronts.
100% Money back guarantee if any project is rejected due to non-compliance issue by any regulatory authority.
We will get back to you with in 24 hrs.
