About Us — Pharma ACTD Dossiers
Who We Are
Pharma ACTD Dossiers is a trusted global partner in pharmaceutical regulatory services, dossier compilation, and compliance management. With over two decades of combined expertise, we act as a strategic extension of your R&D and regulatory affairs teams, ensuring your products meet the highest international standards.
Our consultancy is built on Pharma Regulatory Intelligence™, anticipating evolving health authority expectations to reduce submission risks, accelerate approvals, and secure market access worldwide.
Pharma Administrative Documentation
We specialize in preparing and reviewing critical administrative documents that form the backbone of successful submissions:
- Writing registration applications & covering letters
- Drafting letters of authorization
- Reviewing GMP, CoPP, FSC, and other legal/administrative documents
- Drafting and reviewing pack inserts (PILs)
- Preparing SmPCs and patient information leaflets
- Designing compliant labels and carton content
- Providing justification for fixed‑dose combinations
- Compiling global patent information and literature for patented products
- Writing PSURs (Periodic Safety Update Reports)
Technical Documentation
Our technical writing team ensures dossiers are scientifically robust and regulator‑ready:
- Writing & reviewing quality, clinical, and non‑clinical summaries
- Compiling and reviewing Drug Master Files (DMFs)
- Drafting clinical & non‑clinical overviews (Module 2)
- Preparing PDRs, process validation, AMVs, and stability studies
- Reviewing specifications, methods of analysis, and certificates of analysis for raw materials and finished products
- Writing & reviewing Modules 4 and 5
Pharma ACTD Dossiers Mission
At Pharma ACTD Dossiers, our mission is to deliver timely, accurate, and cost‑effective regulatory services in a rapidly changing pharmaceutical market. We empower clients to navigate complex global frameworks with confidence and transparency.
Pharma ACTD Dossiers Vision
We aim to be a global leader in regulatory services and dossier compilation, offering value‑added solutions that help pharmaceutical companies maintain compliance, accelerate approvals, and achieve commercial success.
Pharma ACTD Dossiers Focus
Our focus is on collaboration and innovation. We work closely with clients from early product development through licensing and lifecycle management, providing tailored solutions that safeguard compliance and strengthen competitive advantage.
Why Choose Pharma ACTD Dossiers
- Global Reach: Experience across 40+ countries with diverse regulatory frameworks
- Quality First: Every dossier undergoes multi‑tier QA checks
- Technology Driven: Expertise in eCTD publishing tools (Lorenz, EXTEDO, Veeva Vault) and PV databases (Argus, ArisG)
- Compliance Assured: Adherence to ICH, WHO GMP, ISO, and 21 CFR Part 11 standards
- Client Centricity: “Your product is our product” — we treat every submission with the same care as our own
