We believe that the challenges and opportunities that face our clients should always be evaluated from multiple perspectives. Major decisions are best made considering the integrated nature of drug/biological development in order to take into account the nonclinical, clinical and CMC contributions and effects to the regulatory process. This can be especially critical when planning and coordinating projects to meet global objectives.
At PharmaLex Development Services (PDS), we cross-train our consultants so they understand the integrated relationship of pharmaceutical development disciplines; our consultants with clinical expertise also know how to anticipate and identify process and regulatory issues that are likely to arise, while our CMC experts can identify cost-effectiveness issues and other challenges that can emerge during Nonclinical studies. Ensuring our team has this full-spectrum development expertise across functional areas is a key to our – and your – success.
Every client’s need is unique. Some depend on outsourcing every aspect of development, from pre-clinical studies through NDA or MAA submission.. Other clients have expertise in Clinical Trials but have had less experience in or fewer available resources for early stage development. Others may have a deep pipeline and as a result are resource-constrained and need help managing the development of a growing portfolio or assistance with specific therapeutic or functional areas.
With extensive experience on the business side of pharmaceuticals, PDS understands the trade-off between time, money, and resources. Whether you are trying to meet investment milestones, beat competitors to the market, or generate data for a funding milestone, you can rely on PDS to provide expert advice and service – on time and on budget.
PDS staff members represent a crucial blend of scientific and business experience. Our expertise ranges from early stage Nonclinical development planning, regulatory submissions, meetings and communications, early stage CMC problem solving through product scale up, clinical development planning, and operational management to QA/QC services to support our client’s business development and corporate goals. Intelligence, curiosity, a passion for problem solving, outstanding analytical and communication skills, discipline, and objectivity are the qualities that define our staff. We thrive on finding solutions to complex issues..
PharmaLex Development Services brings outstanding value, fresh ideas, and new perspectives to our clients. We help you achieve meaningful results quickly, using a combination of creativity, analytical rigor, objectivity, and meticulous project management. Our experience spans the development spectrum — from early discovery and pre-clinical studies, to Phase I – IV trials.