Welcome to

The SPD Company

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With decades of local and international experience at

the coalface, The SPD Company’s specialists have built

a solid repertoire of in-depth technical and management

expertise within the highly-regulated pharmaceuticals,

medical devices, biotechnology, OTC, complementary

medicines and animal health industries.

 

The SPD Company offers in-depth knowledge, guidance,

hands-on support and training in Regulatory Affairs,

QA, Product and Drug Development, as well

as Manufacturing site development.

 

 

SPD’s slogan from confusion to clarity epitomises its approach in every project. SPD strives to put the right people, systems, skills and knowledge in place.

 

The ultimate measure of SPD’s success is when the client's need for SPD’s services becomes redundant. That’s when SPD’s job is truly done.

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Our Vision

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Us

"We aim

to help companies who operate in highly technical and regulated industries,

by offering clear solutions

to complex problems."

Dr Clive Simon

the Principal Consultant of the

SPD Company, leads our team of

specialist consultants.

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Our Specialties

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Who We Are

The SPD Company’s clients include a number of local and global pharmaceutical, medical device and biotech companies, for whom we have successfully completed a wide range of projects across the areas below:

Offering strategic,

hands-on and training

support to your company.

Helping you negotiate the

minefield of guidelines,

regulations and rules

within the TGA, FDA and in

Europe during the product

approval process.

Helping you

upgrade or implement

QMS to GMP, ISO 13485

or ISO 9001, as well as

internal and external

audit preparation.

Providing

technical advice and

feasibility for the

potential purchase of

product ranges,

manufacturing sites and

companies, both in

Australia and

overseas.

Commercialising

your new product

and drug development

strategies, as well as

optimising products,

processes and

systems.

Sourcing and

designing prototype to

full-scale manufacturing

and providing input to

the supply chain

processes.

Empowering

your legal teams with

specialist knowledge

and understanding

during litigation

proceedings.

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More Info:

 

 

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Contact Us:

Email

theSPDco@bigpond.net.au

LinkedIn

linkedin.com/in/clive-simon-spdco

Telephone

0402 546 792

Address

PO BOX 1915 Macquarie Centre NSW 2113 Australia

© 2018 The SPD Company Pty Ltd.

All rights reserved.