HartmannWillner
Hartmann Willner is a company dedicated to providing expert legal services, with a focus on client satisfaction and professional excellence. They aim to deliver comprehensive legal solutions tailored to their clients' needs.
Industries
Nr. of Employees
small (1-50)
HartmannWillner
Products
FDA Regulatory Consulting
Provides guidance and support for navigating FDA regulatory processes, including submission preparation and compliance for biologics, biosimilars, and biologic device combination products.
CMC Consulting Services
Offers consulting services for chemistry, manufacturing, and controls (CMC) to ensure compliance with GLP, GCP, GMP, GCLP, and CLIA regulations.
Biologics Consulting Services
Assists in the development and regulatory approval of biologics, including cellular and gene therapies, vaccines, allergenic extracts, tissues, blood products, and recombinant proteins.
Biosimilars Consulting
Conducts immunogenicity risk assessments and develops assays to measure antibody levels for biosimilar products to meet regulatory approval requirements.
Biologic Device Combination Products
Guides the development of combination products that include biologics and devices, ensuring compliance with FDA regulations and conducting necessary human factor studies.
Regulatory Affairs Services
Provides regulatory affairs services including preparation and review of FDA submissions, meeting preparation, and post-marketing pharmacovigilance.
FDA Regulatory Consulting
Provides guidance and support for navigating FDA regulatory processes, including submission preparation and compliance for biologics, biosimilars, and biologic device combination products.
CMC Consulting Services
Offers consulting services for chemistry, manufacturing, and controls (CMC) to ensure compliance with GLP, GCP, GMP, GCLP, and CLIA regulations.
Biologics Consulting Services
Assists in the development and regulatory approval of biologics, including cellular and gene therapies, vaccines, allergenic extracts, tissues, blood products, and recombinant proteins.
Biosimilars Consulting
Conducts immunogenicity risk assessments and develops assays to measure antibody levels for biosimilar products to meet regulatory approval requirements.
Biologic Device Combination Products
Guides the development of combination products that include biologics and devices, ensuring compliance with FDA regulations and conducting necessary human factor studies.
Regulatory Affairs Services
Provides regulatory affairs services including preparation and review of FDA submissions, meeting preparation, and post-marketing pharmacovigilance.