Regulatory Affairs
With over 10 years of regulatory experience, our expert Regulatory Affairs team, based at our Global HQ, provides a broad range of tailored regulatory services to support:
- All phases of product development and approval
- Lifecycle management
- Manufacturing and distribution activities and authorisations.
We demonstrate a strong global footprint, with regulatory experience spanning the EU, US, UK and other global territories.
Investigational New Drug/Clinical Trial Application Services
We offer regulatory support for Investigational New Drug (IND) Clinical Trial Application (CTA) activities. Our team has extensive experience in preparing drug substance and product CMC documents for Phase 1, 2 and 3 studies. This includes drafting, reviewing, compilation and submission of documentation for:
- US investigational New Drug Applications (IND)
- EU/UK Investigational Medicinal Product Dossiers (IMPD)
- Equivalent documents for other countries
Additionally, we provide support for responding to authority Requests for Further Information (RFIs). We work with you to bring your clinical candidates through your pipeline fast and more efficiently.
MA/NDA Services
We also support you with activities for the approval of commercial drug products.
This includes drafting, review, compilation and submission of documentation for:
- US New Drug Applications (NDAs)
- EU/UK Marketing Authorisation Applications (MAAs)
- Equivalent applications in other global territories
Including the required sections / modules:
- Module 1: Administrative and region-specific
- Module 2: Quality, nonclinical & clinical summaries & overviews
- Module 3: Quality (CMC) for drug substance and drug product
- Module 4: Nonclinical (depending on the type of application)
- Module 5: Clinical (depending on the type of application)
Documentation is authored in accordance with Almac’s internal documentation guidance/templates or Client templates. Our in-house electronic Common Technical Document (eCTD) software gives full control over managing, building, validating and publishing eCTD submission sequences. In addition, we provide support for responding to authority Requests for Further Information (RFIs).
Lifecycle Management and other Regulatory Services
We also provide support for:
- Draft/review/compile and submitting post-approval changes for both INDs/CTAs and NDAs/MAAs, including supplements, variations and annual reports.
- Providing support for specific regulatory pathways including:
a. Orphan Drug Designation
b. Expedited development and submission strategies, primarily for the EU and UK - Draft/review/compile and submitting of initial and post-approval applications for site manufacturing and distribution activities in EU, UK, US, Japan, and other global territories.
