n 8 MAY 2015 | PHARMACEUTICAL PROCESSING
nCOVER STORY ■ PHARMPRO.COM
product method development and
validation, product stability testing,
and very soon, in-vitro release evaluation. Formulation and analytical
teams work very closely together in
development efforts – collaborating
on writing the CMC section of IND
and NDA documents.
“Our team understands what the
FDA Dermatology division is looking
for in regulatory submissions, as well
as the best ways to present the data,”
offers Holley. This experience allows
DDL to more efficiently move through
the regulatory process for client devel-
opment programs. Additionally, DDL
offers clinical labeling, packaging and
distribution services with experience in
creating custom labels and packaging.
Holley also admits that every
project and every client brings a dif-
ferent set of challenges. “Sometimes
it’s a retinoid that requires ex-
tensive effort to be stabilized.
Sometimes it’s a peptide with large
molecular weight, and we need to
devise a way to get the API to the
site of action. We are often asked to
modify or optimize existing formula-
tions to improve efficacy, penetra-
tion, safety or elegance. DDL works
hard to ensure the formulation
works well and that the client’s ex-
pectations are exceeded,” he states.
In addition to their expertise in
topical development, DDL prides themselves on being efficient, focused on
quality and responsive to client needs.
“By managing the complete topical product development program,
laboratory teams work together to
support non-clinical and clinical
teams, which allows us to maintain
efficient project timelines and budgets.” Holley adds, “As the company
grows, the focus will be to maintain
a nimble, responsive and efficient
company focused on meeting the
goals of our client’s. DDL doesn’t develop its own products, so our teams
are focused on making our clients’
projects a success. We are equipped
to manage a full topical development
program – we can promise certain
things that a larger company can’t.”
Debra Dow is very clear that DDL is
different from other service providers
in its expertise, technologies and staff.
“We have expertise in the whole process – from starting the formulation to
scale-up. Sometimes companies have
a technology that they’ve built their
business on. We are just a very broad-based, very experienced group of
people that have done a lot of topical
product development,” she states.
Holley adds, “We are bringing clinical and topical development together.
Our team has a better understanding
of the big picture in topical product
development – attaining clinical efficacy. For example, our team members
DDL's understanding of dermatological substances, and the related approval processes, help them
realize a number of efficiencies, and pass them along to clients.