Shivaxy Pharmaceuticals

REGULATORY

END-TO-END REGULATORY AFFAIRS,
OPERATIONS

Shivaxy : a Global Perspective to Submission Publishing

Key areas of expertise

Global clinical/regulatory strategy development Regula tory submissions and procedures Chemistry, manufacturing, and controls (CMC)
Product information and labelling
Regulatory informatics and regulatory operations services
Lifecycle maintenance at global and local affiliate level
Clinical trial applications (IND/CTA)
eCTD services

Shivaxy provides dossier submission services worldwide, supporting both eCTD and Non-eCTD electronic submissions [NeeS] formats. All submission services are supported by our experienced regulatory intelligence team, whose deep knowledge of local and regional guidelines ensure the provision of compliant and efficient regulatory publishing services. We can help streamline your end-to-end submissions management process, from dossier development to health authority interactions.

CMC Consultancy & Management

Chemistry, Manufacturing, and Controls activities span the entire drug development lifecycle, from preclinical research to post-market surveillance

Our CMC Services Include

CMC Regulatory Gap/Impact Assessment
CMC Regulatory Submissions
CMC Quality Assurance and Compliance
CMC Risk Assessment and Mitigation
CMC Literature Review and Analysis
CMC Documents authoring/co-authoring
CMC Dossier Development
CMC Clinical Trial Support
CMC Post-Market Surveillance

REGULATORY LABELING

Supporting client requirements from creation to maintenance of global and local drug product labelling. Our team of highly qualified medical experts can help ensure that the most up to date information is expressed in the labelling documentation to patients and healthcare practitioners.

LIFECYCLE MANAGEMENT/POST APPROVAL ACTIVITIES

After your product receives approval, multiple changes can occur which may or may not have an impact on its registered details. Our team of experts are focused on maintain the compliance of your product, and can support you with predicting changes, understanding change complexity, and designing the best regulatory strategy for submissions and change implementation, all geared to ensure your product remains available on the market uninterrupted.

Variations could be under European procedures, where we will act immediately after RMS approval to ensure smooth implementation, or during national procedures, and in either case we are here to fully support you every step of the way with extensive regulatory intelligence and local representation in your countries of interest.
We closely monitor all submissions and approvals and follow-up quickly with authorities. Our aim is to manage your change implementation while ensuring no interruption to product supply or out of stock situations.

STAY CONNECTED

with our blogs

Mastering GMP/GDP Audits: Conducting In-depth Investigations for compliance at Shivaxy Pharma

In the ever-evolving landscape
of the pharmaceutical industry,
maintaining rigorous standards
of quality and compliance
is paramount

Life Cycle Management of Products at Shivaxy Pharma: Ensuring Quality from Inception to Obsolescence

In the dynamic world of pharmaceuticals, the journey
of a product from concept to
discontinuation is a complex
and meticulously managed process.

Ensuring Safety and Efficacy
at Shivaxy Pharma: A Commitment
to Excellence

At Shivaxy Pharma, the safety
and efficacy of our products
are the cornerstones of our
mission to improve patient
health worldwide.