In today’s markets, new-product expansion, greater access to information and compressed product life cycles intensify competition, making ever-increasing product portfolios more difficult to manage.
At Pam Lewis & Associates, we understand how critical it is to get your product to market quickly. We founded our reputation on scientific competence, attention to customer needs and timely delivery of services. We provide quality research and customized solutions—on time and within budget. We also help our clients navigate the medical, scientific and regulatory landscape. Our service and quality make your life easier and your business better.
Pre-formulation
Physical characterization – assess appearance, pH, specific gravity, viscosity, taste, odor and flavor.
Excipient compatibility studies – evaluate solubilities, use levels, pH range and temperature preference.
Container/closure identification – recommend container selection, spec appropriate material and source and customize packaging.
Formulation
Prototype development – develop, sample and optimize prototype.
Stability testing – test container/closure, pH viscosity, appearance and specific gravity and spec finished product (bulk, packaged and stability).
cGMP compliance – manages cGMP (current Good Manufacturing Practice) compliance for support of Phase 1
Pilot and commercial formulation process development – draft manufacturing process with critical parameters identified.
Project management – manage drug development process and explore risk analysis and alliance management issues.
Quality and compliance auditing –perform audits on contract manufacturers according to current GMP and GLP.
Regulation compliance consulting – review master batch records, standard operating procedures and specifications, and provide regulatory support for 510K devices and new and abbreviated drug applications.
