Regulatory Affairs
How does your business benefit?
Komply help organisations navigate the thicket of regulatory and compliance requirements before, during, and after commercialisation.
We aid you in efficiently and effectively managing regulatory affairs challenges arising at all stages of the product life cycle. Komply can help with:
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Facility licensing,
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Product registration and listing,
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Preparing, compiling, and reviewing submission dossiers,
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Designing and managing clinical studies,
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Managing scientific data and statistical evaluation, and
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Post-market regulatory feedback or product testing, and associated responses.
We work to ensure your organisation meet obligations set by regulatory bodies, including:
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Therapeutic Goods Administration (TGA),
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Australian Pesticides and Veterinary Medicines Authority (APVMA),
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Medsafe New Zealand,
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Agricultural Compounds and Veterinary Medicines (ACVM),
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Food and Drug Administration (FDA),
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European Medicines Agency (EMA),
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Medicine and Healthcare Products Regulatory Agency (MHRA),
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Veterinary Medicines Directorate (VMD), and
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Health Sciences Authority (HSA).
Whether you’re a start-up or mature organisation, you can contact us to discuss all your regulatory needs.
Industries we work with
Pharmaceutical
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Active Pharmaceutical Ingredients (API)
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Finished Dose Form i.e solids (e.g. powders, tablets, capsules), liquids (e.g orals, injectables), steriles, and freeze-dried
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Prescription medicines, Over-the-Counter (OTC), complementary & herbals
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Biologicals
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Blood & Blood Components
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Drug and device combinations
Veterinary Medicine
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Active Pharmaceutical Ingredients (API)
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Finished Dose Form i.e solids (e.g. powders, tablets, capsules), liquids (e.g orals, injectables, drenches, dips), steriles, and freeze-dried
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Biologicals
Food and Beverage
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Dairy
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Processed & ultra-processed foods
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Allergen management & control
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HACCP
Logistics
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Transportation
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Warehousing
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Distribution
In Vitro Diagnostic Device (IVD)
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Class I, II, III, IV (TGA – Australia)
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Class I, II, III (US FDA)
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ELISA
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Diagnostic disease screening
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Lateral flow
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Immune diagnostic
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Chip/capillary
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Capture systems
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Injectables
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Point of Care (POC) or self-testing
Medical Device
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Classes I, Is, Im, IIa, IIb, and III (TGA - Australia)
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Classes I, II, and III (US FDA)
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Lowest, low, moderate, and high risk (TGA – Australia)
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Simple & complex
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Disinfectants & sterilants
Cosmetics and Sunscreen
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Primary sunscreens
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Secondary sunscreens
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Listed therapeutics
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Registered therapeutics
Other
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Testing laboratories
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Building and construction (laboratories & cleanrooms)
Standards applied in our work
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PIC/S Guide to Good Manufacturing Practice for Medicinal Products
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US Code of Federal Regulations
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ISO 13485:2016 Medical Devices – Quality Management Systems – Requirements for regulatory purposes
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ISO 14971:2019 – Medical devices – Application of risk management to medical devices
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ISO 9000 Standards Series (including ISO 9001 – Quality management systems – Requirements)
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Veterinary GMP codes
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HACCP, Food Standards Code, and Food Safety Systems (FSSC 22000)
What sets Komply apart?
Leveraging over 30 years’ experience in leading national and multinational biotechnology, contract manufacturing, and consulting organisations, we provide reliable and personalised service.
We believe consulting should be as educative as it is troubleshooting. We transfer knowledge, skills, and experience from consultant to client, and inspire organisational self-sufficiency. You will leave knowing you can tackle challenges without significant external help.
Our tailored, flexible, and client-centric approach means you can rest easy knowing your goals will always be met.
