Revolutionizing Therapeutic Innovations

BIOLOGICS

Demeter Therapeutics understands the complexity of biologics development and the differences between pharmaceutical and medical device development. Our Demeter Therapeutics has years of experience that go beyond FDA Title 21 CFR Parts 1271 & 1272, product development, current good tissue practices and quality compliance.

Demeter plays a vital role in the biotechnology revolution, let our biologics experts help you at every stage of your biologic product development from conception to commercialization. Demeter Therapeutics can provide the following services:

  • Nonclinical testing and verification

  • Clinical trials coordination

  • Pharmacology/Toxicology

  • Total quality management

  • Biologics manufacturing

  • Good tissue practices

  • Good manufacturing practices

  • Good clinical practices

  • Good laboratory practices

  • Standard operating procedures

GMP Standard

Our Demeter Therapeutics will guide you through the correct protocol to prevent transmission of infections and diseases by using strict testing and plasma dilution algorithms. We can help with tissue, tissue-based products, vaccines, blood products, cellular and gene therapies and other leading biologics. Our team can help on short-notice and work around the clock to meet your internal and external deadlines. Demeter has built good relationships with CBER FDA agents, let our experience and relationships work for you.

Product Development

Conduct regulatory reviews to evaluate client’s biologics product and provides a strategy that offers their product to market the quickest. Provide product development design plans for biologics, small molecules, combination devices, and biosimilars. Assist with nonclinical pharmacology and toxicology requirements for biologics. Provide Good Laboratory Practices (GLP), Good Clinical Practices (GCP), and Good Tissue Practices (GTP) assistance. Offer complete Quality Management System (QMS) implementation and review. Oversight for clinical trial planning and CRO selection

FDA Compliance Ready

Lead or participate in formal FDA meetings. Prepare and assist with briefing packages for FDA and Advisory meetings. Engage the FDA in a positive manner to obtain the responses needed for a successful meeting. Analyze and assess gaps in submission requirements. Review, compile, write and submit BLA applications. GTP, GLP, and GCP compliance, Gap assessments, Data audits, Facility and personnel audits, FDA Mock Audit on-site or virtual

Your One-Stop for Biomedical Innovation

Demeter Therapeutics is a full-service regulatory and product development consulting firm for biologics, pharmaceuticals and medical devices. Demeter has become the go-to consulting partner for companies large and small seeking to bring innovative, safe and effective products to market within the U.S.

Demeter therapeutics was founded on the premise that biotechnology, medical devices, and pharmaceuticals hold the promise of a better future for everyone. Making good on that promise requires innovative approaches, world-class science, regulatory know-how and a team dedicated to bringing all of it together.

In the nearly three decades since its founding, Demeter Therapeutics has assisted clients all over the globe to address nonclinical, clinical, product development, and regulatory compliance challenges. We are FDA Consultants.