Regulatory Services
Navigating Complex Regulatory Landscapes (FDA, EMA, MHRA, TGA & ROW Market)
MONOGRAPH PHARMA RA team is a niche scientific and regulatory consulting group. We guide and assist pharmaceutical, biotech and healthcare companies in the design and implementation of innovative and global regulatory strategies in order to expedite product development and registration of drugs, biologics, medical devices, combination products, and other healthcare products for all stages of development.
We are a team of experienced regulatory professionals in regulated markets (FDA, EMA, and MHRA, TGA), semi regulated markets and non-regulated markets who advise and provide regulatory support for products in all stages of development (preclinical to post-market). We collaborate with companies to bring products to the market in the most efficient and cost-effective manner, within an evolving and increasingly challenging regulatory environment.
As your partner, we can negotiate the potential assessment minefield of regulatory compliance services with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and regulatory compliance consulting. We offer the following pharma consulting regulatory affairs services for pharmaceutical companies.
- New Product Support
- Product Lifecycle
- Other Regulatory Services
- Combination Products
Global Regulatory Strategy
Facilitating the seamless registration of pharmaceutical manufacturing facilities to meet both domestic and global regulatory standards.
Providing prompt and thorough responses to regulatory queries, ensuring smooth progress in product approval processes.
Offering comprehensive assistance during regulatory audits to ensure compliance and successful outcomes.
Outsourced Regulatory Services
In a competitive business world, pharmaceutical companies use regulatory agencies to often run lean on staff and resources. A staff shortage can slow normal business operations and make it difficult to deliver quality and timely solutions to your customers and end users. Instead, many companies choose to work with MONOGRAPH PHARMA. for ongoing support or special projects where time and quality are of the essence.
We can provide outsourced management solutions to:
