Regulatory Affairs

WELCOME TO ENGEL, HELLYER AND PARTNERS

Engel Hellyer & Partners Pty Ltd is a leading technical consulting organisation for the pharmaceutical, nutritional food, complementary medicine, medical device and cosmetic toiletry industries. Experts in the entire Regulatory Affairs process.

Established in 1982 and located in Sydney, Australia we have extensive experience in dealing with government, companies and industry associations in these areas. Our qualified staff of experienced graduates have personal contacts at senior levels of the Therapeutic Goods Administration, NICNAS, state health departments, contract manufacturers and laboratories.

We also have direct association and experience in assisting clients with product launches and compliance with regulatory requirements in Australia and New Zealand.

OUR SERVICES

We have a range of knowledge and experience in pharmaceutical, nutritional food, complementary medicine, medical device and cosmetic toiletry industries.

 

Regulatory Affairs:

  • Current regulatory awareness
  • Early warning of changes in relevant areas of regulation by regulatory authorities on industry
  • Confidential assessment of potential safety or health risks for products
  • Confidential review of advertising claims and their substantiation
  • Assistance with the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) and the Australian Inventory of Chemical Substances (AICS)
  • Co-ordination between industry and agencies with respect to technical, scientific or toxicological evidence
  • Technical assessments for acquisitions
  • Provision of information to marketing personnel as required
  • The review of products for compliance to the National Trade Measurement Act and Regulations.

Cosmetics:

  • Confidential review of ingredients in cosmetic products to ensure they are on the AICS and are not restricted by entries in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP)
  • Confidential review of packaging to check country of origin, trade measurement and ingredient labelling compliance
  • Advice on cosmetic versus therapeutic claims
  • Advice on claims for new or competitor products
  • Advice on manufacturing, marketing, import or export of cosmetic products
  • Assistance with registration with NICNAS as a cosmetic or industrial chemical importer
  • Interaction with NICNAS to notify or exempt new ingredients not on AICS including writing notifications and permit applications
  • Advice on the safety or health risks of cosmetic or industrial chemical ingredients and products
  • Advice on the writing of Material Safety Data Sheets (MSDS’s) to the Australian approved format
  • Advice on compliance with NICNAS Cosmetic Guidelines and Cosmetic Standard
  • Compliance with Environmental Risk Management Authority (ERMA) New Zealand Group Standards including the Cosmetic Group Standard.

Medicines, Sunscreens and Disinfectants

  • Compilation and submission of applications for:
    • Registrations for Therapeutic Goods onto the Australian Register of Therapeutic Goods (ARTG)
    • Listings for Therapeutic Goods onto the ARTG via the TGA’s eBS website
    • New excipients to be added to the ARTG via the TGA’s eBS website
    • Medicine/poisons scheduling to the Advisory Committee on Medicines Scheduling (ACMS) and Advisory Committee on Chemicals Scheduling (ACCS)
    • Product areas include OTC medicines, complementary medicines, nutritional supplements, traditional medicines, sunscreens and disinfectants.
  • Confidential review and assistance with the following for Therapeutic Goods:
    • Advice on claims for new or competitor products
    • Ingredients
    • Packaging and labels
    • Potential safety or health risks
    • Importing, exporting, manufacturing and marketing
  • Compilation and review of published medical and scientific data for inclusion as supporting evidence in submissions and presentations to government authorities e.g. Therapeutic Goods Administration (TGA) Australia and the New Zealand Medicines and Medical Safety Authority (Medsafe):
    • Submissions to TGA of APIs and Complementary Medicines Actives
    • Submissions to TGA of data and excipients
    • Personal representation to government health departments (state and federal)
    • Related Product Notifications to Medsafe (NZ)
    • Medsafe (NZ) registrations
  • Safety assessment and assistance with respect to:
    • Pharmaceutical, herbal and sunscreen actives
    • Finished products
  • Technical assessment and assistance with respect to:
    • Good Manufacturing Practice
    • Self GMP audits
    • Stability studies
    • Finished product specifications
    • Sponsor/ Manufacturer GMP contracts
    • Quality Assurance documents

Medical Devices

  • Compilation of inclusions for Therapeutic Devices onto the ARTG via the TGA’s eBS website
  • Confidential review and assistance with the following for Therapeutic Devices:
    • Advice on claims for new or competitor products
    • Ingredients
    • Packaging and labels
    • Device application audits
    • Importing, exporting, manufacturing and advertising review
    • Notification of Therapeutic Devices to Medsafe (NZ) via Web Assisted Notification of Devices (WAND)

Foods:

  • Review of formulations for conformity to the Food Standards Australia New Zealand (FSANZ) Food Standards Code
  • Advice on food laws and fair trading laws
  • Advice on Food Safety Standards and hygiene regulations
  • Confidential review and assistance with the following for foods:
    • Advice on claims for new or competitor products
    • Ingredients
    • Packaging and labels
    • Potential safety or health risks
    • Generating supportive data for claims
    • Importing, exporting, manufacturing and marketing
  • Personal representation to government authorities
  • Technical assessment and assistance with respect to Good Manufacturing Practice (and internal auditing)

Dr Renée Badenhop

Director

BSc(Hons), PhD (Medicine), MIP (Master of Industrial Property), Registered Patent & Trademark Attorney

Has 13 years post graduate experience in medical sciences and 4 years consulting experience as a Registered Patent & Trademark attorney. She received a Bachelor of Science at the University of Sydney and Bachelor of Science (Honours) at Macquarie University and in 1997 she was awarded a PhD (Medicine) at the University of UNSW. In 2005 she completed a Master’s Degree in Industrial Property at the University of Technology and was registered as a Patent & Trade Mark Attorney.

She has been employed at one of Australia’s leading Medical Research Institutes, publishing over 15 articles in major scientific journals and presenting her work at over 10 international conferences. She has been employed as a Senior Scientist on both international and local research collaborations with multinational pharmaceutical companies and hospitals in the field of medical genetics.

More recently she was employed at a top tier Patent & Trade Mark Firm as a Patent Attorney in the life sciences/biotechnology area. And in 2007, she took on the role of Chief Operations Manager at a start-up medical device company where she was responsible for Product Research & Development and Regulatory Affairs. She joined Engel Hellyer & Partners Pty Ltd as a Director and Consultant in February 2013.

www.engelhellyer.com

www.engelhellyer.com/the-team

www.regulatory-affairs.com.au

http://www.linkedin.com/profile/view?id=277654987&locale=en_US&trk=tyah

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