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Although BE study is just a part of the complete generic drug product development, it is one of the most critical part of the whole process. There is every possibility that you have managed to develop a perfect formulation, but it does not guarantee you a successful BE study. The industry has witnessed many instances where almost perfect formulation could not achieve the desired results. We believe in preparing better for the BE study in order to reduce the risks associated with most important assets in development for your company. We at Pharmadesk, with experienced team and an efficient cross functional team with expertise in QA, Project Management, Formulation Development, Analytical and Bioequivalence are well equipped to foresee the challenges from every perspective and have conducted more than 500+ study feasibilities. With every assessment we provide a complete feasibility assessment report which includes study design, sample size estimation, inclusion and exclusion criteria, safety parameters, pharmacokinetic sampling time points, bioanalytical specifications, appropriate statistical design etc A few pennies now can save dollars later!
A successful BE study starts with the right study design and appropriate protocol. Designing the right protocol is a skill we have acquired it after years of experience in the domain and handling huge number of BE studies with exceptionally good success rate. The BE protocol depends on multiple factors such as developed formulation, relevant health authority regulations, study design, bioequivalence criteria and the type of volunteers required etc. With the assistance of an in-house formulation development professional, we make sure that we understand the formulation in detail before moving ahead with determining the study design and sample size which meets the requirements of the target regulatory authority. A team of medical writers and QA personnel prepare the study protocol so that BE study can be initiated. Overall Pharmadesk has a huge experience of handling bioequivalence studies and would be pleased to guide / help you from any challenged involved in the successful conduct of a BE study. First right step towards successful end of the journey!
When the whole industry is facing a severe challenge of quality & compliance, it is difficult to find out the right CRO for your BE studies. Even some of the bigger companies have faced irreversible damage due to failure in selection of right CROs for their projects. With the latest incidences of non-compliance, most of the health authorities have become more vigilant. Pharmadesk has been working with a number of CROs since inception and has managed to keep the quality standards high through stringent SOPs. Till date we have audited 25 plus CROs at national and international level and we boast a track record of complete compliance as none of the BE studies managed by Pharmadesk have faced issues with any of the health authorities. We also enjoy a strong relationship with most of the renowned CROs providing us a cost benefit which we always pass on to the sponsor. Selection of a perfect partner is half the battle
When you focus completely on the product which is your core strength you need someone to take care of the BE study on your behalf. The BE study has multiple stages where you need domain specific knowledge for perfect execution of the study. Monitoring the study merely doesn’t mean being a spectator; there are a lot of processes which need careful observation and vigilance. Pharmadesk has a proven track record of managing complex BE studies supporting various ANDA & eCTD submissions. We have been involved in more than 400 BE studies with almost 100% success rate. We take complete ownership and responsibility of your project and ensure flawless execution. We have a cross functional team of experts which works closely with the CRO making sure that every step of the BE study is executed with perfection and with strict adherence to the protocol and relevant regulatory guidelines. It is like having your own aide at the BE study site making sure that you do not miss out on anything. "However beautiful is the plan & the strategy, you should occasionally look at results"
A BE study loses all the importance if it is not analysed and present properly. The analysis and presentation of bioequivalence study is as important as the conduct of bioequivalence study itself. It is indeed a challenge to analyse the data as per the guidelines of the specific health authority and present it as per the requirement. Every health authority has its own requirements and priorities. There have been cases in the past where companies failed to review the data generated after the BE study correctly and ended up with a rejected submission. With years of experience in supporting generic bioequivalence submissions for international regulators such as US FDA, MHRA, EMEA, TGA, Health Canada & other regulatory agencies, Pharmadesk has developed an unmatched skillset of reviewing the data. With an in-house team specialized in quality assurance, data review, analysis and reporting, we are well placed to cater to most of the regulatory agencies requirements. Utmost care is to be taken during review and compilation as it plays a direct role in obtaining the approval and earliest possible availability of medicines in the generic market which in turn translates into business for the company. Pharmadesk is proud of the fact that we have a complete understanding of the analytical phase of the BE studies and can handle complex molecules with ease. Let's not get lost in the data - analyze it to perfection!
A failed BE study is nothing but a major setback of time, opportunity and resources for the company. There can be multiple reasons behind failure of a BE study and repeating the study without knowing them may turn out to be another blunder. Investigation of failed bioequivalence study is beyond the scope of a CRO and is a big loss to the sponsor financially as well as it delays the timelines. As a company you cannot expect the same team to find out the loophole in a study which conducted it. You need an independent entity to assess the BE study and help you with the root cause analysis. We at Pharmadesk with experience team of formulators, formulation analytical development, regulatory, medical writing and quality assurance auditors, are able to resolve good number of formulation and biostudy related issues and are able to sort out the reason for failure and put forth new strategies in planning new bioequivalence study. A thorough investigation of the failed study right from review of dissolution profile, formulation issues, study design, enrolled population, sampling time points, validation parameters, pharmacokinetic interactions and several other factors help us to identify the root cause of failure and choose appropriate steps to conduct the further study. We enjoy almost 100% success rate in the repeat of BE studies where we have diagnosed the root cause of failure and rectified it. Well, if it fails then it has to be rectified rather than dumping it!
Our business development team will contact you and arrange telecon.