Regulatory Affairs Consulting Service

IPCS supports companies in Australia and from around the world with an efficient and reliable regulatory affairs service.

What is regulatory affairs?

Regulatory Affairs is all about ensuring compliance - compliance of ingredients, claims and packaging.  Governments introduce legislation to regulate goods and services in the marketplace by putting in place various agencies to monitor these goods and services. Regulatory Affairs is very specific within the health, food and personal care industries in Australia and overseas. Failure to comply can potentially be devastating for a company.

Why introduce regulations?

It is quite simple - to ensure the manufacturing of products and the end products, are of a high quality and are safe, effective and consistent when used as directed. The bottom line is to protect the average consumer throughout use, including the information available through marketing and at the point of sale.

Why would I use a Regulatory Affairs Consultant?

The many and varied regulations and their tributaries are very intricate. Unless you are well versed in Regulatory Affairs, the process can be very overwhelming. Unfortunately not knowing the regulations is not an acceptable excuse for not complying before releasing a product to the market place, it is expected that you have performed the right regulatory checks. If you r product, ingredients or advertising does not comply, regulatory authorities can enforce removal from the marketplace and could impose fines. Having a good Regulatory Affairs consultant will ensure compliant product and marketing material and eliminate regulatory risks. Taking a global approach to regulatory consulting can also save you money and this is where IPCS stands to help you best.

At what stage should you engage the help of a Regulatory Affairs Consulting Service?

Our recommendation is at concept stage. Regulatory approval is required whenever a new therapeutic good or cosmetic, veterinary or industrial chemical is to be introduced into Australia, whether by manufacture or importation. The regulations for the above mentioned products have been developed by different government agencies to ensure that these products and their manufacture are of a high quality and that they are safe and effective when used as directed. Why waste valuable time and money developing a new formula and heading toward manufacturing the product only to find an ingredient inclusion is illegal or something else in the formulation is incorrect. A Regulatory Affairs Consulting Service ensures you are doing the right thing, the right way, from the beginning.

Why would I choose IPCS Regulatory Affairs Consulting Service?

IPCS Regulatory Affairs Consulting Service has years of experience within the food, cosmetic, personal care and complementary healthcare industry. We also ‘walk the walk’. We are contract formulators so we know what is involved in manufacturing requirements, chemical, herbal, natural ingredient importation and exportation. We also constantly consult with the relevant Government Agencies, as well as provide training.

IPCS Regulatory Affairs Consulting Service is solutions focussed and has an unparalleled reputation for efficient and reliable service. IPCS Regulatory Affairs Consulting Service gives you results for your money in a very condensed time frame. In short – not only are we professional and efficient, but we work to save you money in the long run.

What aspects can IPCS Regulatory Affairs Consulting Service deal with?

To name a few...

• Investigating ingredient compliance

• Product development

• Registration and notification of cosmetic chemicals

• Consultation, mediation and liaison with various agencies such as TGA, NICNAS, ACCC, APVMA, FSANZ and AQIS

• Responses to regulatory authorities and notices of non-compliance

• Importing products into Australia

• Exporting products from Australia

• Preparation of product information files to export product

• Overseas regulations

• Training and implementing Good Manufacturing Practice (GMP)

• Advertising Codes

• Novel Food applications

• Raw Material and finished product specifications

• Quarantine issues

• SUSDP (poisons schedule) issues

• Products at the cosmetic/therapeutic or food/therapeutic interface

• Discuss risk assessments

• Assistance with meeting various regulatory obligations

• Meeting all relevant food, nutritional and labelling requirements

• Assist in determining whether goods require a certificate or permit or may have restricted entry into Australia

• Registering agricultural or veterinary chemical products with APVMA

• Claims and evidence requirements

• Labelling and packaging requirements

• Levels of Evidence sourcing and documentation – scientific and/or traditional evidence

• Training in basic regulatory affairs – reading and understanding documentation

We at IPCS Regulatory Affairs Consulting Service are experts in our field and we want you to achieve your regulatory approval the first time round. IPCS Regulatory Affairs Consulting Service can provide you quality service at every level – small or large, providing as little or as much assistance as you need at an extremely competitive price.

We help you get it right the first time.

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