G&A Associates is
a recently formed API development company specializing in
providing ANDA and NDA holders with the peace of mind they
need from their API supplier as they bring their products
to market. Our team has years of experience in developing
APIs for the regulated markets. Our strength is the ability
to build compliance and regulatory requirements into our
development process resulting in an efficient transition
from samples, to scale up, to validation, to approval and
launch. Our customers can trust that we will take care of
everything for the API.
Compliance
Our team is trained to not just identify compliance issues
with our partners but also to offer solutions that take
into account the customer, the FDA and the practical realities
of the factory. This results in solutions that are feasible
to implement and ensures that it complies with cGMPs.
We have implemented a comprehensive compliance program
based on the Six System FDA approach that routinely monitors
and trains our partners to the current industry standards.
At a minimum, our protocol includes audits every 6 months
with increasing frequency as we prepare the factory for
an FDA inspection. During the FDA Inspection we manage
the inspection by providing translators trained to work
with FDA. We help correct potential observations and if
there is a Form 483 issued we help prepare the response.
Each of our Managers have at least 20 FDA / EU inspections
worth of Experience.
Regulatory
Each member of our team has the experience of having developed
and compiled over 20 DMFs. We also have experience working
closely with FDA whenever deficiencies are issued to the
DMF or to the ANDA. Because we have regulatory in mind
when we develop our products, we can anticipate potential
regulatory inquiries from FDA and proactively address
them prior to becoming a deficiency or rapidly respond
to them ensuring that your approval does not get delayed.
Our aim is to make API sourcing the
least difficult part of your development, your approval,
your launch and your commercialization.
