Services
Regulatory Affairs
Global Regulatory Reach. Local Expertise. We deliver end-to-end regulatory strategy across 34 countries through an integrated network of scientific, clinical, and regulatory partners — guiding your programme from first-in-human to global approval.
Jurisdictions
TGA (Australia) · FDA (United States) · EMA / National Competent Authorities (EU) · MHRA (United Kingdom) · Medsafe (New Zealand) · Health Canada (Canada) · HSA (Singapore)
Services
• Clinical Trial Applications & Notifications (CTA/CTN) and Investigational Drug Applications
• Market Approval Submissions — NDAs, BLAs, ODAs, PIPs/PSPs, Priority Review & Provisional Determination
• Pre-IND / Pre-CTA meetings and scientific advice
• Question development & agency briefing document preparation
GRS will help you get to
Market
Product Development
Do you have a drug or device candidate but don’t know where to start on getting it to market? Our team can work with you to guide your product from the bench, to market through the preparation of a specific Product Development Plan (PDP) for your candidate. We can advise you on the quickest and most cost-efficient way to market. Our plan includes:
- Target Product Profiles (TPPs)
- Competitor Product Analysis
- Chemistry, Manufacturing, & Control/ Quality Reviews
- Non-Clinical & Clinical Development Pathways
- Regulatory Strategies
- Cost Estimates & Timelines
- Vendor Resourcing Strategies
- Risk Management Strategies
Clinical Support
At Graythan Regulatory Services, we partner with sponsors and developers to deliver seamless clinical trial support across every phase of development.
From first-in-human Phase I studies through to pivotal Phase III programmes, our team draws on decades of international experience spanning pharmaceuticals, biologics, advanced therapy medicinal products, and medical devices — bringing both strategic depth and hands-on operational capability to every engagement.
Our clinical support services encompass protocol development and review, investigational product regulatory strategy, ethics committee and regulatory authority submissions, Clinical Trial Notification (CTN) and Clinical Trial Approval (CTA) pathway management, GCP compliance, safety reporting, clinical monitoring, and Trial Master File oversight — all executed with the rigour and precision that regulators and sponsors demand.
For sponsors requiring broader operational support, GRS offers end-to-end CRO solutions tailored to your programme’s scale, therapeutic area, and geography — drawing on our established partner consortium to deliver monitoring, data management, biostatistics, and site support as a fully integrated service.
Vendor / Program Management
Graythan Regulatory Services has a vast network of quality contract clinical and manufacturing organisations we can add to your programs.
Our vendor management services will help you to reduce your operational costs, improve your service delivery, and retain internal focus on higher strategic value development activities.
Our services include:
• Vendor Management Plans (VMPs),
• Gap Analysis,
• Vendor Assessment & Selection,
• Clinical & Manufacturing Oversight,
• Distribution and Supply Chain Management.
Gene Therapy Applications / IBC
GRS has over 30 years of experience with gene technology regulatory submissions. We have extensive experience in preparing your DNIR/ DIR application for the IBC review.
The GRS IBC is a team of senior professionals in this field who have the proficiency to review your gene therapy application and the authority to officially approve your DNIR/ DIR/ NLRD application for submission to the Office of the Gene Technology Regulator (OGTR). Our IBC services include:
• Dealings Not Involving Release (DNIR),
• Dealings Involving Release (DIR),
• Notifiable Low-Risk Dealing (NLRD)
• Accrediting your organisation with the Office of the Gene Technology Regulator (OGTR),
• Filings to the New Zealand Environmental Protection Agency (EPA) and Ministry of Primary Industries (MPI)
• Writing of GMO SOPs for your organisation
• Handling exempt dealing designations and exemption letters
Trust our
IBC Service
Your Australian Presence,
Managed
Resident Australia Director Support
GRS leadership was instrumental in obtaining global artesunate approval with Amivas — bringing first-in-class injectable artesunate through FDA, EMA, and MHRA regulatory pathways for the treatment of severe malaria.
Entering the Australian market should not require building an entire corporate infrastructure from scratch. Graythan Regulatory Services provides comprehensive Local Entity and Resident Director Support, acting as your in-country executive presence to satisfy regulatory, legal, and governance requirements without the overhead of establishing a standalone subsidiary.
Our services cover director and corporate governance support, statutory compliance, and annual tax filing, alongside expert guidance on Australia’s Research and Development Tax Incentive (RDTI) — a Federal Government programme offering eligible companies a refundable tax offset of up to 43.5% on qualifying R&D expenditure. For sponsors investing in clinical development or preclinical research on Australian soil, this represents a significant source of non-dilutive funding.
Medical Writing
Need assistance in developing essential documentation for your program? We can support you in the production of:
• Clinical Trial Reports (CSRs)
• Clinical Trial Protocols (CTPs)
• Investigational Brochures (IBs)
Choose Graythan to ensure the success of your drug development program
At Graythan, we strive to add value to our client’s drug development programs through expert advice on regulatory and commercialisation pathways and by facilitation of regulatory processes.
Talk to us today about how we can make a difference with your drug development program, and make it a success.
Extensive Knowledge
Our many talented people have up-to-date in-depth knowledge of the life sciences industry
Our Journey
We work closely with you to guarantee our services are tailored to your company’s specific needs
Proven Results
We have a strong track record of success, coupled with high client retention rates and quality assurance
Personalised Support
Each client has their own GRS Consultant who ensures your needs are met to ensure product success