April 11, 2016

CMC & Quality

PharmaDirections got its start doing CMC consulting, and CMC is still close to our heart as a company. It is not a single discipline, and excellence in execution requires more than a single expert. Whether you have a small molecule, a peptide, or a protein, whether you need an injectable, a topical, or a controlled release oral, whether you are looking for approval in the U.S., Europe, or elsewhere, we have the experts to help you get there.

Small Molecule Development

Pharmaceutical chemistry is not as simple as designing a scalable synthetic scheme.  What isn’t in your API is every bit as important as what is, and testing for related compounds, residual solvents, and potential genotoxic impurities is as important as establishing proof of structure.  Our experts will help you get the right vendors, generate the best synthetic scheme, and develop all the necessary analytical methods to get you from lab-scale to clinical-scale to commercial.

Large Molecule Development

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 are needed to control for everything that can go wrong with a 100 kDal protein.  PharmaDirections’ large molecule experts have the knowledge and experience to shepherd your API from its petri dish origins to commercial-scale fermenters.  Beyond just proteins, we have helped clients develop peptide and protein conjugates, oligonucleotides, genes, and even whole cell therapeutics.

Drug Product

Since its inception, PharmaDirections has been working with clients and vendors to design final dosage forms that balance safety and efficacy as well as maximizing marketability and intellectual property protection.  Please see our Dosage Form Design page for more information.

Quality and CMC Regulatory

The second C in CMC stands for Control, and this is where much of our CMC expertise comes into play.  Our individual subject matter experts are highly experienced in meeting requirements for each stage of development and in preparing CMC sections of regulatory applications, but in addition to them, we also engage Quality specialists to perform the duties of a virtual quality assurance unit.

A specific offering many of our clients utilize is generation of a limited quality system to fit the needs of a virtual sponsor.  While vendors take responsibility for the bulk of quality-related work, final responsibility for the drug product remains in the hands of the sponsor even if all work is outsourced, and at least a small number of SOPs are needed to detail what needs to get done and who needs to do it in order to allow drug into the clinic.