Explore our world-class
biologics solutions
Innovation Supported by Our Expertise Here
at Freshstart Lifesciences
Biologics are large, complex molecules that are produced by living cells. They are used to treat a wide range of diseases, including cancer, arthritis, Crohn’s disease, and psoriasis. Biologics are made from a variety of sources, including humans, animals, and microorganisms.
Biologics are an important part of the future of medicine, and it is critical that we continue to invest in research and development in this area. To learn more about biologics and their potential to improve the lives of patients, read on!
The global market for biologics was valued at $179 billion in 2015 and is expected to reach $536 billion by 2025. Biologics are typically larger, more complex molecules than small-molecule drugs, and they are produced by living cells. As a result, they are more difficult and expensive to develop and manufacture.
This blog will provide an overview of biologics, including their structure, function, and therapeutic applications.
We strive to provide the highest quality biologics products available on the market. Our goal is to maintain outstanding service and supplier relationships that make us your partner of choice for all your biologics research
needs.
Explore our biologics solutions
Our pharmaceutical consulting services include drug development guidance and
regulatory strategies for all stages of the U.S. Food and Drug Administration (FDA) drug approval process, as well as special assistance for international clients. Through our pharma consultancy, we serve as your development partner from planning for your initial FDA meeting to the commercialization of your product.
Our management team has a deep understanding of current regulatory philosophy and standards. We have direct experience in working with the Food and Drug Administration (FDA) at all levels. Our history as a successful drug development and pharma consulting company spans a wide range of therapeutic categories including anti-viral, neurology, oncology, gastroenterology, and OTC products.
We will be your partner & guide through the FDA Drug approval process.
Pharmaceutical Formulation Research & development
Our services span all stages of pharmaceutical formulation development including preformulating studies and analytical methods development,
as well as qualification and validation. We have specialized technologies for formulation development and optimization of oral, topical and parenteral
formulations. Our innovative solutions are unique to each compound and may allow our clients to expand their intellectual property portfolios. We are experts in formulation development of Difficult to Develop Products and Novel Drug Delivery Technologies.
Analytical Method Development & Support
Our team have developed and validated analytical methods for hundreds of products. Such methods enable the quantification of drug level in novel formulations. Analytical methods are also a requirement for drug product release in GMP clinical and commercial manufacturing.
We develop, validate, qualify and transfer analytical techniques and methods that are used to quantify drug substance purity and the percentage of drug
content in a dosage form.
We design and conduct studies to determine the physical and chemical characteristics of the compound of interest, including small organic molecules,
peptides and proteins.
Clinical Supply Manufacturing & Logistics Support
We have the capabilities to support our clients’ clinical manufacturing needs. Our clinical trial manufacturing department has demonstrated expertise and compliance with Good Manufacturing Practices (GMP) regulations for the clinical manufacturing of pharmaceutical formulations for clinical studies
and specialty pharmaceutical products. We understand the chemistry, manufacturing, and control (CMC) guidelines that underscore successful CMC
clinical manufacturing.
We have the experience and capacity to produce a wide range of dosage forms in our state-of- the-art clinical manufacturing facility. We provide packaging and labeling and our clinical manufacturing organization provides pharmaceutical products in dosage forms needed by our clients.
