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Our Services
Strategy
Submission, Registration and Lifecycle Management
Submission, Registration and Lifecycle Management
Submission, Registration and Lifecycle Management
Submission, Registration and Lifecycle Management
Submission, Registration and Lifecycle Management
Strategy
Global Pharma Consultants is an experienced and skilled consulting group that can provide strategies and ideas for subjects like:
- New Drug Applications (NDAs) – 505(b)(1) and 505(b)(2)
- Abbreviated New Drug Applications (ANDAs) – 505(j)
- Over The Counter Drugs – Monographed products
- Drug Master Files (DMFs) – API and Packaging
- Medical Devices - Class I, II, and III Devices
- Cosmetic Registration per MOCRA
- Facilitate meeting with the Healthcare Authorities
- Work as liaison between sponsors and healthcare authorities to obtain necessary clarification, if needed.
Submission, Registration and Lifecycle Management
We provide regulatory guidance throughout the product journey, from inception to a commercialization. Subsequently, we ensure commercial viability of the product through life cycle management.
We specialize in -
Submission and Registration
- eCTD (NDA & ANDA)
- eCopy (devices)
- Drug listing (OTC Drugs)
- Cosmetic Registration (in compliance with MOCRA)
Lifecycle Management
Supporting post-approval changes to the products.
Analytical Services
- Assist with Protocol & Report writing and review
- Provide guidance on Drug product method validation activities
- Provide guidance on Drug substance method validation activities.
Technical Writing
- Help author and review CMC sections for the submission documents
- Assist with Technical Report writing and Review
- Help author and review CTD module for Module 2.3 and Module 3.