Services

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)

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 of dossiers, SmPC, PIL, Packaging, Labeling & inserts, CRFs, clinical trial protocol & report etc to 60 + languages; viz European, Russian, ASEAN etc.

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.

Readability Testing
Our counterparts in EU who have a panel of volunteers on whom the testing is carried out as per Article 59 (3) of Directive 2001/83/EC and customer specific requirements.

Our experienced packaging designer will support you in the packaging development. We can manage your entire artwork system, from creation through to post-licensing maintenance and packager liaison.

Colour mock-ups of the leaflet and labels, meeting all the applicable guidelines and suitable for submission to regulatory authorities, can be provided

Artwork is provided as PDF files suitable for electronic submission.

Writing of QA, QC, Production, R&D and Corporate QA SOP’s
Review and revision of existing SOP’s
Audit to identify need for new SOP’s and prepare new SOP’s
Preparation and review of packaging material and raw material specifications
Preparation of quality manual and Policy for the company
Preparation of Safety, health and environment related SOP’s
Review existing MFR’s and revise to meet regulatory requirements
Preparation of annual product review and trend analysis
Preparation and revision of Site Master File
Preparation and revision of Validation master Plan
Review and revision of protocols for various types of validations
- Process Validation
- Analytical validation
- Cleaning validation
Protocols for DQ, IQ, PQ and OQ for equipments
Other GMP documents
Review of documents and approvals from regulatory agencies to identify gaps and non compliances

We conduct comprehensive audits as per the requirements of GMP auditing, ISO, UK-MHRA, MCC, TGA, in house or other standards as required by you.

We audit the following segments

API / Excipient / Packaging materials Vendor
Analytical and stability centres
Formulation and manufacturing sites
Clinical and preclinical study centres

Imparting SOP training to different departments
Imparting GMP training to different departments
Imparting training to face national and international audits

REGULATORY SERVICES

Types of Services

» Regulatory Services

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