Regulatory Support

We offer Regulatory Affairs and GMP compliance services for product registration and GMP accreditation for US/EU/EDQM/AU/Health Canada and other Regulatory authorities.  

SCORP Pharma also has a strong arm in serving as a Regulatory Affairs and GMP compliance consultant. We offer our support to our clients for their Regulatory and Product registration requirements in US, EU, AU, CA and other regulated and non-regulated markets. We also help overseas Pharmaceuticals companies for product registration in India as well as vendor selection procedures. We have elite and skilled employees who gradually well understand needs and requirements of regulatory authorities norms that enlighten our clients need for product registration. 

Our core function as a Regulatory Affairs consultant is preparation of DMF/DMS/EDMS/CEP/ASMF along with assisting our client to provide support for GMP compliance as well as audits. We provide Comprehensive Solution for Preparation, Compilation, Submission and Maintenance of DMF/CEP/ASMF for API for US/EU/AU/CA and other Regulatory authorities. We also undertake first-to-last GMP compliance project from our clients who are looking to establish Regulatory environment.   

We offer our service in the following area:


1) Expertise in Preparation, Compilation and Submission of Drug Master File in CTD format for US (USDMF), EU (EDMF/ASMF), EDQM (CEP), Health Canada (DMS), TGA (ASMF) and other countries.      
 

2) Submission of DMFs in different formats like eCTD (Electronic) submission, NeES submission & Paper submission. 

3) Annual maintenance of DMF life cycle and other Regulatory database through Amendments, Annual Reports, Change Notifications, Variations, Renewal etc. ·    

4) Assisting to Respond Queries/Deficiencies/Audit observations as well as Closure/Reactivation of DMF.     

5) Strategic planning of preparation, compilation and timely submission of Response to Queries/Deficiencies raised by Regulatory agencies and customers.   

6) Submission of Administrative informations, LOA (Letter of Authorization), Site registrations, Communication with Regulatory agencies on behalf of DMF holder etc.

7) Identification and review of Technical data required to furnish in the submission.

8) Expertise in review of technical document required for Regulatory submissions as well as GMP Audit concern like: 
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 - SOP, BPCR/MPCR, COAs, Stability data, Impurity profile and its control, Characterization study etc.
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 - Route of synthesis and Manufacturing process
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 - Genotoxic impurities evaluation and non-carry over studies.
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 - Vendor qualification for starting material
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 - Process validation and Analytical method validation study
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 - Change controls and its impact on regulatory submissions, Deviations, OOS and OOT etc. 
 

9) Compilation of Applicant Part and Technical Packages for customers. ·      

10) Preparation and submission of application for Domestic registration like Manufacturing License, Product addition, State GMP, WHO GMP, COPP, etc.


11) Assisting our clients during triggered by Regulatory agencies and GMP experts.
  12) Performing audits on behalf of our client for vendor evaluation and approval. 

DMF - CEP - Dossier - Technical Documentation Support - GMP Documentation - Audit - Procurement Assistance

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