Regulatory affairs is a profession which developed to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.
The companies responsible for the discovery, testing, manufacture and marketing of these products also want to ensure that they supply products that are safe and make a worthwhile contribution to public health and welfare.
Our Service includes Developing Regulatory Strategies, Comprehensive Documentation, Submission and Archiving of Documents.
Our Core Competencies
- Dossier Generation as per CTD, eCTD, ACTD & ROW
- Preparation and Submission of Drug Master File (DMF)
- Preparation of Site Master File (SMF)
- Reply to Queries
- Writing Expert Reports
- PSUR writing
Services we offer
Preparation and development of dossiers:
To comply with the international regulation, TradeStone provides efficient timeline and flexible dossier services. We offer all kind of dossiers as per international regulations like CTD, eCTD, ACTD and all other country specific guidelines.TradeStone offers complete dossier preparation including below parts:
- Document preparation and dossier compilation
- Sample generation; From artwork designing to final registration samples with reference standard*
- Other documentation support like BA/BE, CT, etc.
- Support for legalization and notarization of documents.
Preparation and submission of Drug master file (DMF):
TradeStone provides quality DMF preparation and submission services. We offer DMF preparation as per CTD format and having expertise in preparation of all type of DMFs like type I, II, III and IV.
We also provide DMF sourcing for various kinds of markets.
Preparation of site master file (SMF):
TradeStone provides SMF preparation for all kind of facilities like Tablet, Capsule, Oral liquids, Injectables (Liquid, dry powder and lyophilized), Topical, Hormonal, Cytotoxic, APIs.
Product development reports:
For making your product developments more perfect TradeStone provides preparation of product development reports as per enterprise and country requirements. We offer development reports to contract developers with premises and third party scale up support.
TradeStone offers protocol and reports of process validation for commercial scale batches. Our expertise team also facilitate technical support to validate the methods and generation of process validation reports at customer premises.
The TradeStone advantage
- Single step consultancy for all regulatory services
- Confidentiality of the documents with CDA
- Cost effective regulatory support
- Round the clock regulatory support like In-house regulatory department
- Dossiers and DMfs in all guidelines
- Timely services
- Post submission and post registration support
- More priorities to query reply
- Re-registration support
Regulatory challenges to successful TradeStone adoption include the following:
- Periodic training for updating guideline knowledge
- Cost per dossier
- Specific market experience