- Our Team
- Drug Safety / Pharmacovigilance
- Regulatory Affairs
- QA & Compliance
- Clin-Ops & Biometrics
- Clinical Development
Our consultants are highly qualified in their respective functional area. Each is vetted using our proprietary methodology to ensure the integrity of their specific backgrounds in the life sciences industry. Ultimately, our goal is to provide our clients with practical consulting solutions which properly address the situation at hand.
In today’s pharmaceutical, biopharmaceutical and medical device product landscape, you can’t afford to miss crucial safety information about your products. From preclinical studies to post-marketing settings, BioPoint has the broad-based experience to provide comprehensive clinical and post-marketed drug safety consulting and pharmacovigilance training services to help you address product safety concerns in a confident, proactive manner.
The Life Sciences industry is heavily regulated. Medicines would never reach market without the expertise of regulatory professionals to ensure products in development are meeting global regulatory standards. At BioPoint we understand the importance of properly navigating a complex global regulatory arena. We have a diverse global network of regulatory affairs specialists and experts available to support our clients’ development lifecycle from preclinical through product approval.
HEOR Consulting from BioPoint provides our clients the ability to address today’s ever increasing demands to make sound evidence based business decisions. The emphasis on local and international Health Technology Assessment and regulatory requirements necessitates robust HEOR planning throughout a product’s life cycle. Our clients need as much data as possible and the most meaningful information to support key internal and external stakeholders.
BioPoint understands how important it is to your company that your quality systems work efficiently and comply with the current domestic and international regulatory requirements. As the regulatory landscape around clinical development evolves, it is vital for our clients to meet regulatory expectations and still remain competitive in the marketplace.
Life Sciences organizations today are under increasing pressure to conduct clinical trials that show efficacy, safety, cost-effectiveness, and differentiation, often with fewer resources and in less time.
Pharmaceutical companies must deliver safe and efficacious compounds as timely and as cost-effectively as possible. Addressing this central problem requires a clinical competency that can not only quickly and efficiently evaluate the safety and efficacy of potential new products, but also maximize the value of post marketed products.
Moving a small or large molecule from bench to bedside is a lengthy and resource intensive process that also comes with great risk. Products would never reach market without the expertise of clinical development professionals to address nonclinical and clinical strategy, medical / regulatory writing, and commercialization.