ARCIEL
Arciel provides regulatory consulting services focused on the development and approval of investigational drugs, biologics, biotechnology products, combination products, and dietary supplements. Their mission is to support success in regulatory affairs through efficient and effective strategies, including submissions management, FDA communications, and liaising with regulatory agencies. They also offer expertise in CMC, nonclinical, clinical development, and international regulatory consulting.
Industries
Nr. of Employees
small (1-50)
ARCIEL
Wallingford, Connecticut, United States, North America
Products
US FDA Regulatory
Regulatory consulting services for development of investigational new drugs, biologics, biotechnology products, combination products, and dietary supplements including submissions management, FDA communications, and regulatory writing.
US FDA Regulatory Submissions through Pointerro, LLC
Services for document lifecycle management, regulatory writing, publishing (paper and electronic), ESG setup and E-transmissions for FDA regulatory submissions.
US FDA Regulatory
Regulatory consulting services for development of investigational new drugs, biologics, biotechnology products, combination products, and dietary supplements including submissions management, FDA communications, and regulatory writing.
US FDA Regulatory Submissions through Pointerro, LLC
Services for document lifecycle management, regulatory writing, publishing (paper and electronic), ESG setup and E-transmissions for FDA regulatory submissions.
Services
Advisory services on regulatory pathways and development strategy for investigational drugs, biologics, combination products, and dietary supplements targeted to US and non-US filings.
Operational management of submission packages, preparation for FDA formal meetings, and acting as sponsor liaison to regulatory authorities including acting as US IND agent when required.
Authoring of clinical study protocols, clinical study reports, and regulatory application sections required for INDs, NDAs, BLAs, and other marketing applications.
Engagement coordination with external experts to provide CMC, nonclinical toxicology, and complex clinical development support under separate consulting agreements.
Document lifecycle management and regulatory publishing services (via regulatory operations partner)
Document lifecycle and regulatory publishing services including preparation of paper and electronic submissions and electronic transmissions to regulatory authorities.
Advisory services on regulatory pathways and development strategy for investigational drugs, biologics, combination products, and dietary supplements targeted to US and non-US filings.
Operational management of submission packages, preparation for FDA formal meetings, and acting as sponsor liaison to regulatory authorities including acting as US IND agent when required.
Authoring of clinical study protocols, clinical study reports, and regulatory application sections required for INDs, NDAs, BLAs, and other marketing applications.
Engagement coordination with external experts to provide CMC, nonclinical toxicology, and complex clinical development support under separate consulting agreements.
Document lifecycle management and regulatory publishing services (via regulatory operations partner)
Document lifecycle and regulatory publishing services including preparation of paper and electronic submissions and electronic transmissions to regulatory authorities.
Expertise Areas
- Regulatory submissions and strategy (IND/NDA/BLA/MAA)
- Sponsor liaison and FDA meeting support
- Clinical protocol development and CSR authoring
- CMC and pharmaceutical product development
Key Technologies
- eCTD / electronic regulatory submissions
- Document lifecycle management systems
- Regulatory writing and publishing workflows
- Clinical protocol and CSR authoring methods