PharmaGreen

We apply our understanding to the complex and sometimes bewildering regulatory environment to develop creative yet considered solutions, navigating regulatory frameworks to get the best possible outcomes. We love a reg affairs challenge!

Our key Reg Affairs services include:

• Expertise in regulatory processes of the US FDA, EMA, TGA, APVMA, Medsafe (NZ), and other regulatory agencies

• Develop and execute global regulatory strategies for product development and commercialisation programs supporting business enter new markets

• Compliance review and advice for Consumer Medicine Information leaflets, product labelling, packaging, product claims

• Medicines registrations including dossier review and gap analysis for medicines – including medicinal cannabis – specialising in Modules 2 & 3

• Medical device registrations, assessment of technical files in relation to Essential Principles, design, and development controls

• Licencing requirements – ODC, Poisons, TGA, import/export, AQUIS/BICON

Maintaining supply to the market is critical for every business. PharmaGreen recognizes the complexity of getting medicinal products to market. Starting with a secure supply chain for starting materials, ensuring the integrity of the product when it gets to the user, and everything in between. We can help by:

• Building company infrastructure including facility design, equipment selection, commissioning, & validation

• Optimising operational effectiveness

• Supply chain analysis, qualification and oversight including Good Distribution Practices, audits, monitoring & review

• Logistics such as Import/Export process, warehousing, transport studies

• Identification vetting, and selection of strategic manufacturing & distribution partners with the right amount of GMP

PharmaGreen engages with sponsors, suppliers, cultivators, and manufacturers to deal with any issues, concerns, or problems practically, promptly and professionally so that the best quality products are delivered to patients.

Building in Quality to every aspect of a business – Quality by Design – starts with attitude & culture. Applying a pragmatic approach to Quality and its cost-effective application, PharmaGreen creates practical and useable systems to enable manufacturing, production excellence and ultimately, the success of the business.

Expertise in Quality Assurance, Quality Control, Systems & Validation includes:

• Authorised & Responsible Person including Release for Supply

• Compliance auditing for local & international cGMP, GLP, GDP, GACP

• cGMP Certification strategy including audit preparation, audit strategy, and responses

• Stability strategies that are robust, cost effective, and achievable including program oversight, study design, data analysis, interpretation & reporting to ICH requirements

• Quality, safety and environmental integrated management systems

  • Quality system for ISO9001, ISO13485, & Pharmaceuticals inc. PIC/s & FDA 

  • Development of procedures, design control, risk management, Medical Device Technical File & Drug master files/dossier documentation 

• Product specifications for physical, chemical and microbiological testing

• Analytical method development & validation

• Validation & Verification of facilities, clean rooms, production equipment, cleaning, process, storage, transport laboratory &analytical

Problem solving & technical reports such as Quality by Design, stability, shelf-life determination, auditing, technical risk assessments, & root cause analysis investigation, etc.

Interest and expertise encompass all stages of product development from concept to commercialization. PharmaGreen can advise across a range of products including medical devices, pharmaceuticals, through research, experimental design, process development, synthesis, formulation, fabrication, scale-up, and market entry including:

• Medicinal Cannabis & other emerging therapeutic goods

• Medical devices – design, fabrication, and testing

• Active Substances (API) manufacturing, development & scale up including liquids, semi-solids, powder/crystalline products

• Medicines manufacturing for finished product such as formulation, primary & secondary packaging for solids, liquids, and herbal dosage forms creating the unit of sale

Technical advice & due diligence on IP development and protection including patents