Pharmaceutical Regulatory Services
ERA (Excellence in Regulatory Affairs) provides
comprehensive regulatory support to pharmaceutical
companies for successful product registration,
compliance management and lifecycle maintenance.
Our team delivers strategic regulatory solutions
tailored to meet national and international
regulatory requirements while ensuring timely
submissions and approvals.
With extensive expertise in regulatory documentation,
dossier preparation and compliance management,
we assist pharmaceutical organizations in navigating
complex regulatory pathways efficiently and effectively.
Our Regulatory Services Include:
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DMF Preparation & Management –
Preparation, compilation, review and maintenance
of Drug Master Files (DMF) in accordance with
regulatory requirements.
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Dossier Preparation –
Preparation of CTD, ACTD and Country-Specific
Regulatory Dossiers for finished formulations
including Tablets, Capsules, Ointments,
Injections, Parenterals and other dosage forms.
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Post Submission Query Response –
Professional support in preparing and managing
responses to regulatory authority queries and
deficiency letters.
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Life Cycle Management –
Support for product renewals, variations,
amendments and post-approval regulatory
maintenance activities.