Atheln is a biopharma consulting agency that primarily focuses on offering product development and commercial strategies.

Biotechnology

Health Care

Life Sciences

Atheln

Atheln's headquarters in San Diego, CA, United States

Monica Alfaro Welling

Paola Lanza

Jane Hart

Adriana E. Manzi

This department specializes in providing expert consulting across various sectors, including strategy, healthcare, and quality control.

Consulting Services

The Commercial Strategy & Operations team at Atheln is responsible for driving the commercial success of biopharma products through comprehensive market analysis, sales and marketing strategies, and business development initiatives. They focus on new product planning, forecasting, and brand management, ensuring effective European commercialization efforts and overall market readiness.

Commercial Strategy & Operations

The Quality Assurance and Regulatory Affairs team at Atheln ensures that biopharmaceutical products and medical devices meet all regulatory standards and compliance requirements. They oversee the implementation of Quality by Design principles, manage compliance for Chemistry, Manufacturing, and Controls (CMC), and navigate global regulatory landscapes to facilitate successful product approvals and market launches.

Quality Assurance and Regulatory Affairs

The Clinical and Non-clinical Development team at Atheln is responsible for designing and overseeing both preclinical non-clinical pharmacology studies, PK/ADME, toxicology, and clinical trials. They ensure that research and development efforts meet regulatory standards and align with strategic product development and commercialization goals.

Clinical and Non-clinical Development

The Biopharmaceutical and Drug Development team at Atheln specializes in enhancing biopharma products through downstream process optimization, CMC (Chemistry, Manufacturing, and Controls) strategies, bioassay development, analytical development, and cell line and upstream process development. They focus on scaling up manufacturing processes, qualifying and validating bioassays, and optimizing single-use bioreactors to ensure efficient and reliable product development and commercialization.

Biopharmaceutical and Drug Development

This department focuses on the non-clinical studies related to pharmacokinetics, pharmacodynamics, and toxicology.

Atheln

Org chart

Teams

Consulting Services

Commercial Strategy & Operations

Quality Assurance and Regulatory Affairs

Clinical and Non-clinical Development

Biopharmaceutical and Drug Development

Pharmacology and Toxicology

Offices

Atheln

Org chart

Teams

Consulting Services

Commercial Strategy & Operations

Quality Assurance and Regulatory Affairs

Clinical and Non-clinical Development

Biopharmaceutical and Drug Development

Pharmacology and Toxicology

Offices

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