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Nature of Business
Service Provider

Legal Status of Firm
Sole Proprietorship (Individual)

Products & Services

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Quality Control Assurance

Ball Bearing
  • To design an appropriate Quality Management System (QMS)
  • To implement any corrective and prevention actions
  • To review and approve all documents (e.g. Validation and Test Plans, Test Protocol and Validation Summary Reports…), Validation Master Plan.
  • To review and provide approve Standard operating procedures.
  • Quality service according to guidelines stipulated by regulatory bodies.
  • Independent review of  DATA
  • Comprehensive review of calibration procedures;
  • Review of Laboratory Investigation Procedures for Deviation and Out of Specification handling meeting FDA regulations.
  • Implementing Effective Internal audit program with effective CAPA system.
  • Co-ordinating inspections and audits by regulatory bodies and customers
  • Database audits
  • Site qualification/audits
  • Quality Systems audits
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ACTD Dossiers Services

The ASEAN (Association of Southeastern Asian Nations) have observed this and are now drafting the ASEAN CTD, a standard derived from the CTD. In place of the 5 modules, the ACTD organized the submission into 4 parts. This is done because ASEAN members usually only receive reference applications — applications to put a drug on the local market that has already been approved elsewhere. As a result, the need for detailed documentation is lessened — most study reports are not required to be submitted.

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CTD Dossiers Services

The Common Technical Document (CTD) is a set of specification for application dossier, for the registration of Medicines and designed to be used across Europe, Japan and the United States. Quality, Safety and Efficacy information is assembled in a common format through CTD .The CTD is maintained by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

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Product Development Services

  • PharmaActdDossiers service has dedicated team for Formulation and Development which work exclusively on NEW MOLECULES including ONCOLOGY Drug.
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Medical Writing Services

PharmaActdDossiers staff has extensive medical writing experience including Pre-Clinical and Clinical Study Reports, INDs, Fast Track Applications, New Drug Molecules and clinical summaries for Safety and Efficacy, ACTD, CTD and eCTD submission format.

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Sample Analysis Services

  • Structural Elucidation Studies (Elemental Analysis, IR, Mass, NMR C H, XRD, DSC),
  • Analytical Report (COA)
Analytical Method Validation
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Pharma Actd Dossiers Gala No.1, Unique Industrial Estate,
Chandigarh-160017, ,India

Hari Ram Goel ( Owner )
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