ABOUT US
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.
Services Available To Clients
Pharma players – Just starting up, desire to expand their business in Regulated as well as Emerging Markets of the Globe.
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Smaller companies, seeking assistance to prepare themselves with Global Regulatory & GMP standards
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Looking for an assistance for product development and regulatory filings/ Handling the queries and Post approval amendments.
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Complete project management / coordination for the facility, QMS and implementation activities on behalf of client or its service providers.
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Compilation of eCTD dossiers and filing assistance using CESP and ESG for EU and FDA respectively.
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Vendor qualification audits, Follow up audits and evaluations at suppliers
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Third party assurance with capable resource available in USA, for USFDA liasonig and coordination
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Support on outsourcing of Regulatory affairs and Quality Compliance function and substantially reducing financial burden of client due to Non compliance issues and remediation activities.
Products and dossiers being handled
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Active Ingredient and Advanced Intermediates
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Intermediate DMF in NeeS and eCTD as per requirement
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CEP compilation and submission to EDQM Formulations
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Oral Solids – Tablets / capsules / Modified Release Formulations
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Oral Liquids
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Topical semi-solids – Gels / Creams / Ointments
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Biologics – India and Emerging Markets filing
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Medical Devices
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EU, CA, AU filings
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Strategy and Paving layout for USFDA filing
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Support for ISO 13485 audit and compliance.
Global Regulatory Strategy
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End To end Regulatory Affairs Project Management
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QMS/ cGMP and Quality Compliance and CAPA activities
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Facility Design and Validation Documentation as per Good Documentation Practices
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Health Authority Inspection support / Pre-inspection Audit Services
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Dossier in-licensing Audit / gap Analysis
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eCTD compilation Outsourcing support *
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EU Dossier Filing facilitation and QP and QC testing support.
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Scientific and Technical Support.
