We’ll take you from lab-scale to clinical‑scale to commercial.
Whether you have a small molecule, a peptide, or a protein, and whether you need an injectable, topical, or controlled release oral solutions, we have the experts to help you – in the U.S., Europe, or anywhere.
Drug Substance
- Small molecule
- Peptides/protein
- Oligonucleotides
- Whole cell
Dosage forms
- Solid dosage – IR, SR, CR
- Solutions, suspensions, emulsions
- Creams, lotions, ointments
- Drug/device combination products
Routes
- Oral
- Parenteral
- Topical (dermal, ophthalmic, intravaginal, etc.)
- Inhalation (pulmonary and nasal)
Some Specialties
- Solubility enhancement
- Stability improvement
- Bioavailability enhancement
- Modified PK profiles
Our experts will help source and secure the right vendors, generate the ideal synthetic scheme, and develop all the necessary analytical methods to move your development project forward.
Proteins, peptides, and nucleotides each present unique challenges in generation, purification, and analysis. While a single chromatographic test can tell you how potent and pure a small molecule is, a whole palette of analyses is needed to control for everything that can go wrong with a 100 kDal protein.
Our large molecule experts have the knowledge and experience to shepherd your API from petri dish to commercial-scale fermentation. Beyond proteins, we have helped clients develop peptide and protein conjugates, oligonucleotides, genes, and even whole-cell therapeutics.
Our team of CMC experts are highly experienced in meeting requirements for each stage of development and in preparing CMC sections of regulatory applications.
Managing quality is a top priority.
At PharmaDirections, we engage Quality specialists to perform the duties of a virtual quality assurance unit. One thing that separates us is that we offer the ability to generate a limited quality system to fit the needs of a virtual sponsor.
Here’s how it works: Vendors take responsibility for the bulk of quality-related work. Yet final responsibility for the drug product remains in the hands of the sponsor even if all work is outsourced. Typically, a small number of SOPs are needed to detail what needs to get done and who needs to do it in order to allow a drug into the clinic.
