Applications Specialists International, Inc - Regulatory Affairs, Quality Assurance & Technical Services - About Us

 Pharmaceutical Products & Services

Applications Specialists International, Inc – The Company

Applications Specialists International, Inc (ASII) specialises in international pharmaceutical registrations. ASII can provide a range of services including the preparation and submission of an application for a new or generic drug, a device or a biologic to the FDA. Services can be offered to US and non-US as well as Europe and non-European countries.

ASII also provides other regulatory services such as the preparation of DMFs, acting as a company agent for the US, preparation of supplements, variations, annual reports and other post-marketing reports and services.

ASII's QA/QC services include cGMP, QSR and ISO compliance audits for companies or any of their contractors and the preparation of SOPs for manufacturing, laboratory or general QA operations.

ASII is a consulting firm located in the US, whose sole function is to provide Regulatory Affairs, Quality Assurance and Technical Services to the pharmaceutical industry or to those companies serving the pharmaceutical industry.

Company Principal

The principal of the company has over 22 years experience in the pharmaceutical industry and 7 years consulting experience. The breadth of experience ranges from devices and drugs to biologics and active drug substances.

Additionally, the principal has a p.H.D. in analytical organic chemistry and is RAC certified by the Regulatory Affairs Professional Society. He is also an ISO 9000 certified lead auditor.

The experience in types of dosage forms ranges from small and large volume injectables, to lyopholyzed products and solid and semi-solid dosage forms. Also the principal has experience in drug delivery in the form of topicals and liposomes.

Internationally Renowned

Finally, our experience is certainly not limited to the US. Companies in Sweden, Netherlands, Canada, Germany, France and several other countries have sought the assistance of Applications Specialists International.

Therefore, if your company is US-based or non-US based, virtual or large or in-between, and you are in need of one or more of the services in our products & services section, please contact us to discuss your needs.

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	Applications Specialists International, Inc
	109 Shore Drive Garner North Carolina 27529 USA
Tel.	+1 919 772 8518
Fax	+1 919 772 1300