Regulatory Affairs

“A powerful Regulatory Affairs process automatically
  takes care of progress, productivity and profits”
Regulatory Affairs

Regulatory Affairs

Regulatory Affairs


Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. Regulatory Affairs also has a very specific meaning within the healthcare industries (pharmaceuticals, medical devices, Biologics and functional foods). Most companies, whether they are major multinational pharmaceutical corporations or small, innovative biotechnology companies, have specialist departments of Regulatory Affairs professionals. The success of regulatory strategy is less dependent on the regulations than on how they are interpreted, applied, and communicated within companies and to outside constituents. Regulatory Affairs plays a crucial role in the pharmaceutical industry and is involved in all stages of drug development and also after drug approval and marketing. The drug development process is a lengthy, complex and extremely costly albeit necessary process. Pharmaceutical companies use all the data accumulated during discovery and development stages in order to register the drug and thus market the drug.




Services Offered


#     Global Regulatory Strategy.
#     End To end Regulatory Affairs Project Management.
#     QMS/cGMP and Quality Compliance and CAPA activities.
#     Facility Design and Validation Documentation as per Good Documentation Practices.

#     Health Authority Inspection support / Pre-inspection Audit Services.
#     Dossier in-licensing Audit / gap Analysis.
#     eCTD compilation Outsourcing support.
#     EU Dossier Filing facilitation and QP and QC testing support.
#     Scientific and Technical Support.

A full Portfolio of Capabilities to deliver Measurable Results for clients


#     Regulatory affairs Market intelligence and filing strategies.
#     Regulatory filings at USA/ EU/ Emerging Markets.
#     Emerging Market Tender activities and support to participate thru capable distributors &
       facilitators.
#     Assist In-house Regulatory Teams to sort and comply filing concerns.
#     Global filing and registration, Life cycle management.

#     Gap Analysis for Market specific requirements – Technical/ Administrative and
        Regulatory.
#     Technical and regulatory support for API and Formulation development activities.
#     Regulatory dossier filing end to end project management.
#     GMP Deficiencies – Regulatory and Quality compliance/ CAPAs / Remediation action>
        Plans.
#     Regulatory and technical aspects – Training onsite as well as Offsite classroom
        trainings.

REGISTERED

Office Address

Vetsi Pharma LLP
C 120 – Jay Yogeshwar Complex,Kudasan
Gandhinagar – 382421
+91 9909001204


info@vetsipharma.com

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