Services

Regulatory Affairs

The pharmaceutical and medical device industry operates in a dynamic and complex regulatory landscape. As medical technology advances, regional legislation and global standards are continuously being revised and updated. Keeping up with the legislation and regulatory processes can be exhaustive and costly. Through our expertise and capabilities, we can help your program comply with the most current challenges to bring your life-enhancing product safely and compliantly to market promptly.

Our regulatory services can support your program’s geographical regionals such as:

  • Australia – Therapeutic Goods Administration (TGA),
  • United States – Federal Drug Administration (US-FDA),
  • European national regulators (including the UK) such as ANSM, BfArM, MEB, MHRA and MPA
  • New Zealand – MedSafe

Our services include:

  • Clinical Submission Preparation
    • Pre-Investigation & Investigational Drug Applications,
    • Clinical Trial Applications, & Notifications (CTA/ CTN)
  • Market Approval Submissions
    • New Drug Applications (NDAs)
    • Biological Licence Applications (BLAs)
    • Orphan Drug Applications (ODAs)
    • Paediatric Investigational Plans (PIPs)
    • Paediatric Study Plans (PSPs)
    • Priority Review Designation requests (PRD)
    • Provision Determination requests (PD)
  • Pre-IND and Pre-CTA meetings
  • Scientific advice meetings
  • Question development & briefing document preparation
Product Development

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

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.

Vendor Management Drug Development Program Assistance
Medical Report Writing

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)

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)

Gene Therapy Applications

Trust our

IBC Service

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.

Get in touch

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