Dossier Creation

We write dossiers that meet all national and international requirements and is in accordance with all legal demands.

Dossier in CTD (modules 1 – 5 or any requisite module) and eCTD formats for worldwide markets like EU, USA, UK, Preclinical and clinical Overviews / Summary writing based on literature search / Published studies / articles from journals .

Dossiers for ASEAN and ROW countries in ACTD/ as per country specific format, for any dosage form.

Dossier reformatting to CTD / eCTD by taking up gap analysis of existing dossiers in line with current requirements.

Product information update (SmPC, PIL and Labeling).

Preparation of Drug Master File and Certificate of suitability (open and closed part) Dossier review and maintenance Our counterparts in Europe take up review of dossiers prepared for registration in EU/UK. We will evaluate your technical data through all stages of the development process, review study protocols and conduct due diligence on your behalf. Provide EU-QP services for Pre-clinical and Clinical modules. Handling of all types of variations (Type Ia, Ib and II), annual reports, renewals of MAAs and support in query responses Translation services Translation of dossiers, SmPC, PIL, Packaging, Labeling & inserts, CRFs, clinical trial protocol & report etc to 60 + languages; viz European, Russian, ASEAN etc. Product Literature & Readability Testing SPC/SmPC, PIL and Labeling Texts

We advise on the regulatory requirements for both content and format under legislation as well as write or review the relevant texts.

Writing services for Summaries of Product Characteristics, Patient Information Leaflets and labeling texts. These documents can be created from scratch or existing texts can be updated to reflect changes in the registered details or to improve readability.

Alternatively, we assess clients’ own product literature, and advise on the medical and scientific accuracy of the statements as well as checking for compliance with the registered details, the legal requirements, applicable guidelines and standard terms.