We Bring Value To Your R&D Investment By Helping You In Sourcing Of Strategic R&D Services. Our Solutions Help Small & Large Bio-Pharma Companies Alike, In Securing Best-In-Class Vendor Services In Flexible Yet Cost-Effective Way.
As a Science focused Small/Medium sized BioPharmayou don’t want to keep large & dedicated teams/individuals for non-scientific roles like Vendor/ Program Selection, Procurement of strategic services etc.. You would rather wish your critical team-members to spend time and efforts on scientific matters, than for them to run an RFP or track a Gantt charts from your vendors.
You might have some R&D operations (most of the routine R&D capabilities) in-house and Vendors for some other activities (e.g. not so frequent, niche activities). At times, you might have all capabilities in-house, but might be short of capacity, when you need them – resulting into a bottleneck for your critical R&D program.
Experts at BioDev manage a network of providers and have deep understanding of their strengths. We can work with you to create a network of strategic service providers specific to your needs. We will ensure that the providers stay committed to your needs and you incur cost only when you use them. The value that BioDev experts provide are:
- Tailored vendor network for you
- Committed vendors with fall-back plans and
- highest attention to your needs. We can work for you to source:
Pre-clinical Discovery:
- Medicinal chemistry
- Formulation strategy & Development
- DMPK profiling
- Toxicity/ toxicology studies
- Translational studies in-vivo, in-vitro
Clinical Development:
- Phase 1/ First in Human
- Other pharmacology studies
- Phase 2 to Phase 4 studies
Regulatory & Launch services:
- Regulatory strategy, FDA interactions, Special status (if any possible)
- Regulatory writing, Publishing & Submission
BioDev experts can collaborate with your internal stakeholders and develop a Sourcing strategy for each of the services and identify
- What to outsource and
- who are the best possible vendors.
Working with your procurement team (or equivalent), we can identify and block capacities with the vendor (or internal departments) so that your R&D programs always stay on track and achieve all progress milestones on time.
Our E2E Program management services include not only Sourcing of vendors, but Program management for the success of your programs from end to end.
More often than not, you would have all R&D capabilities in-house with a very strong Program Management Office (PMO). However at times, your in-house units (and their programs) would be experiencing a stiff competition for capacity. BioDev experts can work with your Program team and other stakeholders – to develop a Capacity/ calendar view for such services, thereby avoiding bottlenecks.
True to the nature of large BioPharma, some of your R&D programs might be of enormous importance from company’s strategy and you may wish to treat this program more intensely compared to other competing programs.
Experts at BioDev manage a network of providers (& a schedule of capacity) and have a deep understanding of their strengths. We work with your teams to create a tailored outsourcing plan for your ear-marked program, with fall-back strategies. Our network of providers includes (not limited to) vendors offering specialized services in:
Pre-clinical Discovery:
- Medicinal chemistry
- Formulation strategy & Development
- DMPK profiling
- Toxicity/ toxicology studies
- Translational studies in-vivo, in-vitro
- Animal pharmacology
Clinical Development:
- Phase 1/ First in Human
- Other pharmacology studies
- Phase 2 to Phase 4 studies
Regulatory & Launch services:
- Regulatory strategy, FDA interactions, Special status (if any possible)
- Regulatory writing, Publishing & Submission
BioDev experts can collaborate with your internal stakeholders and develop a Sourcing strategy for each of the services and identify (a) What to outsource and (b) who are the best possible vendors.
Working with your procurement team (or equivalent), we can identify and block capacities with the vendor (or internal departments) so that your important R&D programs always stay on track and achieve all progress milestones on time.