505(b)(2)-Generic Hybrid

Algorithme Pharma offers scientific guidance in developing clinical study designs to address critical endpoints such as safety, pharmacokinetics and pharmacodynamics in accordance with 505(b)(2) regulatory criteria.

High Quality 505(b)(2) Trial Conduct

The key to a viable 505(b)(2) New Drug Application (NDA) development strategy is identifying existing submission gaps early, and then planning for studies that will effectively bridge those gaps. The most common 505(b)(2) application flaw is the lack of appropriate data to support the proposed modification(s) of the Reference Listed Drug (RLD). As this pathway falls under the NDA application process, it is essential to meet with the regulatory body prior to initiating studies. The objective of the Pre-IND meeting review is to discuss both the scientific rationale and strategic planning behind the 505(b)(2) application.

Recruitment

Recruiting is crucial to the clinical trials process. Our effective approach to recruitment is two-fold.

Clinic

Algorithme Pharma has over 20 years experience conducting clinical trials. Our clinic has 265 beds, located in fully equipped Clinical units including a dedicated long-stay unit.

Data Management

Algorithme Pharma has extensive data management expertise. The quality and integrity of clinical data being entered into our database is a key priority for us.

Project Management

High quality project management is key to the success of a clinical trial.

Regulatory Affairs

Our Scientific & Regulatory Affairs Department is involved in regulatory discussions to assure that the goal of your study meets the requirements of corresponding authorities.

Bioanalytical Services

The Bioanalytical Services Department offers scientific excellence, uncompromised quality and unbeatable timelines to meet and exceed client needs.

Quality Assurance

Algorithme Pharma is committed to the provision of accurate, rapid and reliable results.

Medical Writing

We have developed a strong reputation for delivering a high quality, reliable and responsive medical writing service. Our dedicated team of professional medical writers provides a complete writing service to clients around the globe...

Pharmacokinetics and Pharmacodynamics

The Algorithme Pharma team provides extensive pharmacokinetic (PK) and pharmacodynamic (PD) support in preclinical and clinical studies.

Scientific Affairs

Once your needs have been clearly identified, the Scientific & Regulatory Affairs Department will prepare a study design that best accommodates development needs and effective study conduct.

Statistical Services

Our team has extensive experience in providing a wide range of statistical services.

Clinical Sample Kits & Management Support

Preparing, collecting and shipping clinical samples from trial sites to bioanalysis laboratories is a critical support service when managing clinical programs.