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Quality Assurance, Compliance & Regulatory Consulting

Komply advises and assists clients in end-to-end quality assurance, Good Manufacturing Practice (GMP), registration, regulatory, compliance, audit, and commercialisation matters. 


We provide consulting services to Australian and international regulated organisations in varied industries, including pharmaceutical, medical device, in vitro diagnostic device (IVD), veterinary medicine, food and beverage, and cosmetic.

 

From start-ups to established businesses, Komply is here to help.
 

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Our Services

Industries we work with

Pharmaceutical

  • Active Pharmaceutical Ingredients (API) 

  • Finished Dose Form i.e solids (e.g. powders, tablets, capsules), liquids (e.g orals, injectables), steriles, and freeze-dried

  • Prescription medicines, Over-the-Counter (OTC), complementary & herbals

  • Biologicals

  • Blood & Blood Components

  • Drug and device combinations

Veterinary Medicine

  • Active Pharmaceutical Ingredients (API)

  • Finished Dose Form i.e solids (e.g. powders, tablets, capsules), liquids (e.g orals, injectables, drenches, dips), steriles, and freeze-dried

  • Biologicals

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Food and Beverage

  • Dairy

  • Processed & ultra-processed foods 

  • Allergen management & control

  • HACCP

Logistics

  • Transportation

  • Warehousing

  • Distribution

In Vitro Diagnostic Device (IVD)

  • ​Class I, II, III, IV (TGA – Australia)

  • Class I, II, III (US FDA)

  • ELISA

  • Diagnostic disease screening

  • Lateral flow

  • Immune diagnostic

  • Chip/capillary

  • Capture systems

  • Injectables

  • Point of Care (POC) or self-testing

Medical Device

  • Classes I, Is, Im, IIa, IIb, and III (TGA - Australia)

  • Classes I, II, and III (US FDA)

  • Lowest, low, moderate, and high risk (TGA – Australia)

  • Simple & complex

  • Disinfectants & sterilants

Cosmetics and Sunscreen

  • Primary sunscreens

  • Secondary sunscreens

  • Listed therapeutics

  • Registered therapeutics

Other

  • Testing laboratories

  • Building and construction (laboratories & cleanrooms)

What our clients say

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"Ece Smrdelj and the Komply team have over the last 12 months been providing us with regulatory support to maintain product registrations in Australia and New Zealand.

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Ece is very knowledgeable when dealing with the APVMA and ACVM, providing relevant information in a timely and professional manner. Her support and professional approach is very much appreciated."

Ernst L.

About Us

About Us

Leveraging over 30 years’ experience within leading national and multinational biotechnology, contract manufacturing, and consulting organisations, we provide reliable and personalised services to our clients. 

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Komply's Managing Director, Ece Smrdelj, founded the organisation in 2021 to better address the complexity of client needs. With proven success aiding and advising numerous organisations on product registration, process improvements, quality and GMP matters, Komply are well-suited to tackle any project.

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We work with organisations looking to ensure their facilities, equipment, quality systems, processes, technology transfer, and clinical studies are compliant with regulations and standards from the following bodies, amongst others:

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  • Therapeutic Goods Administration (TGA),

  • Australian Pesticides and Veterinary Medicines Authority (APVMA),

  • Medsafe New Zealand,

  • Agricultural Compounds and Veterinary Medicines (ACVM),

  • Food and Drug Administration (FDA),

  • European Medicines Agency (EMA),

  • Medicine and Healthcare Products Regulatory Agency (MHRA),

  • Veterinary Medicines Directorate (VMD),

  • Health Sciences Authority (HSA).

  • World Health Organisation (WHO),

  • Pharmaceutical Inspection Co-operation Scheme (PIC/S),

  • International Organisation for Standardisation (ISO),

  • International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).

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Komply is committed to meeting your needs. To do so, we use a network of professionals and experts to deliver optimal results. We are available to manage or assist in projects, engage in contract consulting, or simply point you in the right direction. 

 

To help us assess your needs, and determine the relevant scope of works, please contact us.

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Standards applied in our work

  • PIC/S Guide to Good Manufacturing Practice for Medicinal Products

  • US Code of Federal Regulations

  • ISO 13485:2016 Medical Devices – Quality Management Systems – Requirements for regulatory purposes

  • ISO 14971:2019 – Medical devices – Application of risk management to medical devices

  • ISO 9000 Standards Series (including ISO 9001 – Quality management systems – Requirements)

  • Veterinary GMP codes

  • HACCP, Food Standards Code, and Food Safety Systems (FSSC 22000)

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