Hexagon

Regulatory Dossier compilation in CTD and eCTD formats for US FDA and Europe

The Common Technical Document (CTD) is an internationally agreed format for the preparation of applications to be submitted to regulatory authorities in three ICH regions of Europe, USA and Japan. It is intended to save time, resources, easy to distribute for review, facilitate fast regulatory response and trouble-free communications with regulatory agencies.

Hexagon Scientific Services (HSS) have specialized experts:

To compile CTD and eCTD format dossier for US and EU submissions.
To re-format Old Dossier into current CTD format.
To convert CTD format to eCTD (electronic copy) format by using our software.
To manage the lifecycle of eCTD applications.

Abbreviated New Drug Applications(ANDA) in US

TAn Abbreviated New Drug Application (ANDA) is an application for a generic drug approval in USA which can be submitted to FDA's “Center for Drug Evaluation and Research (CDER)” Oficice of Generic Drugs (OGD). FDA reviews the ANDA and provides ultimate approval for a generic drug product. When FDA approves ANDA, the applicant may manufacture and market the generic drug product to provide a safe, effective, and a low cost alternative drug product to the American public.

Hexagon Scientific Services expertise:

To compile ANDA dossier in CTD and eCTD formats for US FDA submission.
Identifying the appropriate regulatory agent.
Identifying the gap between the existing data and potentially required data for submission and approval.
Identifying the appropriate CMC information for regulatory dossiers including suitable specifications for analytical methods (assay, impurity, residual solvents, cleaning), evaluation of analytical method validation parameters, and minimum stability data requirement for submission.
To offer complete guidance and support for ANDA process from application preparation to approval of application.
Aligning client's product development goals along with regulatory requirements.
Arranging for Bioequivalence Studies that acceptable for US FDA.
Engaging fruitful discussions and interactions with regulatory agents.

Marketing Authorization Applications (MAA) in Europe by NP / MRP / DCP

In the European Union (EU), all medicines, originator or generic, have to be authorized before they produced and distributed to patients. The regulatory agency of each EU Member State, or the European Medicines Agency (EMEA) in London, does approving MAA by assessing the safety, efficacy and quality of the medicine. To receive market approval from EU states for a a generic medicine that must be “bioequivalent” to the originator product—i.e., it must work in essentially the same way in the patient's body.

Marketing authorization for a pharmaceutical product in the EU must currently be applied for through one of three procedures: the “Centralized Procuedure (CP), National Procedure (NP) or the “Mutual Recognition Procedure” (MRP), and the “Decentralized Procedure (DCP)”.

Hexagon Scientific Services have expertise personnels:

To prepare, submit and manage MAA through MRP / DCP / National Procdures.
To coordinate and schedule the DCP slot for the year 2010 with certain EU agencies and DCP slot of the year 2011 with all EU agencies.
To advises the best choice of regulatory procedure for trouble-free and fast approval.
To support and guide our customers on the EU member states national requirements for the submission of MAA i.e., additional data requested, number of paper/electronic copies required for filing, filing fee details, labelling requirements and etc.

Quality Overall Summary (QOS), Clinical / Non-clinical Overviews and Summaries

Hexagon Scientific Services have the expertise to guide our clients:

In preparing Quality Overall Summary for regulatory submission.
In preparing Clinical Overviews and Summaries for regulatory submission.
In preparing Non-clinical Overviews and Summaries for regulatory submission.
In offering Clinical and Non-clinical literature search and literatures that required for regulatory submission.

Drug Master Files(US DMF and EDMF) and Certificate of European Pharmacopoeia (CEP)

Hexagon Scientific Services have excellent knowledge:

To prepare the European Drug Master File (EDMF) and the United States Drug Master File (US-DMF).
To reformat DMF to meet current requirements for US / EU regulatory submissions.
To prepare and submit CEP applications to EDQM, responding query letters to CEP and managing the lifecycle until obtaining certification process.
To provide complete support for preparation of necessary documents, and registration of products with FDA / EU agencies and answering 'Post Submission' queries.

Regulatory agency interactions

Hexagon Scientific Services aware that fruitful communications and interactions with Regulatory Agencies are most important to move any Product or Process towards approvals and marketing.

HSS has good experience:

To discuss and interact with regulatory agencies.
To interact with regulatory authorities as Client's Agent.
To provide consultancy services for regulatory interaction issues.

Maintenance of Marketing Authorizations: CMC-compliance, Variations, Supplements

Hexagon Scientific Services offer:

CMC-compliance (Module 3) review of 'Approved Dossiers verses Current Changes and their requirements'.
Consulting services on variation of filing strategy during manufacturing site change.
Preparation and submission for 'Change of Ownership Applications' for approved licenses in EU member states as per national requirements.
Technical guidance and support for the preparation and submission of Type IA/IB/II variations for approved MAAs in EU member states through NP/DCP/MRP.
Technical guidance and support for the preparation and submission of post approval changes for minor, moderate and major changes by supplements / amendments in the approved ANDA.

Deficiency Letter Responses

HSS assists to prepare Responses to Deficiency Letters that received from US FDA and EU member states.
HSS also offers support and guidance on Deficiency Letter issues.

Regulatory Services