Home Services Regulatory, Quality & Compliance

Regulatory, Quality & Compliance

Helping your business achieve the optimum commercial outcome for your products

Navigating the path to regulatory approval and compliance

Our highly-experienced Regulatory, Quality and Compliance team have in-depth knowledge of the complexity of the regulatory environment in Australia and New Zealand. We help to position your products for the best possible outcomes by navigating the various challenges during the approval and life-cycle management process.

We will assist you in the development of effective submission strategies, ensure you are meeting your regulatory requirements, manage your submissions, and enhance your regulatory, quality and compliance activities.

Our consultants have expertise across prescription, over-the-counter (OTC) and complementary medicines, medical devices including in vitro diagnostics and software as a medical device, sunscreens, and cosmetics. We also have electronic publishing experts, who are adept at using a range of software solutions to enhance your regulatory, quality and compliance obligations.

We can help you

We have a trusted history of success, managing over 160 projects each year, including the submission of 60 major applications to regulatory authorities. As such, we understand your unique needs and are perfectly positioned to optimise your business.

Regulatory due diligence and gap analysis
Dossier and technical file evaluation
Competitive intelligence
Presubmission meetings
Resubmission strategies
Bioequivalence and clinical strategies
comparable overseas regulator (COR) pathways
ACCESS consortium pathways
Project orbis pathways
Priority review and abbreviated evaluation pathways
Provisional registration pathways

Technical file evaluation and compilation
Clinical evidence and design examination
Manufacturer’s evidence applications
Conformity assessment
Inclusion applications
Regulatory agency liaison
Portfolio lifecycle management

Dossier evaluation and compilation
Regulatory agency liaison
Submissions for:
- New chemical entities
- New biological entities
- Generics, biosimilars and non-Biological complex generic medicines
- Fixed dose combination products
- Portfolio lifecycle management
Specialty applications including:
- Literature based submissions
- Orphan designations
- Priority review and provisional determinations
- Rescheduling applications
- Appeals
- Restricted representation and exemption methods

eCTD and NeeS electronic publishing
Creation of eCTD baselines
Portfolio lifecycle management

Ingredient/component and labelling assessments
Claims and instructions for use assessment
Regulatory agency liaison
Regulatory applications
Portfolio lifecycle management

Also referred to as ‘Marketing Authorisation Holder’
Available in Australia and New Zealand
Flexibility in structure to meet client needs
Available for pre-market regulatory applications and post health authority approval
Health authority interactions
Compliance with sponsor obligations

Ingredient and labelling assessments
Claims assessment
AICIS/FSANZ/government liaison
Portfolio lifecycle management

GMP and technical agreement reviews
Batch release recommendations
Complaint handling
Medicines shortage notifications
Product quality reviews
Recall management, communication and support
Release for supply
Import and export licences

OUR IMPACT

90+

Clients across the globe

60+

Major applications on average each year

160+

Regulatory projects in the past 12 months

Events & Webinars, Hot Topics, Latest News,

Australia’s TGA CPPs Open Doors to Global Pharmaceutical Markets

TGA Certificates of Pharmaceutical Products (CPPs) are a trusted tool for supporting international medicine registrations, offering regulatory credibility and flexibility across a wide range of global…

Discover more