Life Cycle Management
ERA (Excellence in Regulatory Affairs) provides
comprehensive Life Cycle Management (LCM) services
to support pharmaceutical companies in maintaining
product registrations, regulatory compliance and
market continuity throughout the product lifecycle.
Our experts ensure that all post-approval regulatory
activities are managed efficiently in accordance
with applicable regulatory requirements.
Regulatory compliance does not end with product
approval. Continuous management of renewals,
variations, amendments and regulatory updates is
essential to maintain product registrations and
ensure uninterrupted market presence. We help
organizations manage these requirements efficiently
while minimizing regulatory risks.
Our Life Cycle Management Services Include:
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Product Registration Renewals –
Preparation and submission of renewal
applications to maintain valid product
registrations.
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Variation Management –
Support for minor and major variations,
change controls and post-approval changes.
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Regulatory Amendments –
Preparation and submission of amendments
related to manufacturing, packaging,
labeling and technical documentation.
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Post-Approval Regulatory Support –
Ongoing assistance for maintaining compliance
with changing regulatory requirements.
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Regulatory Gap Assessment –
Identification and management of compliance
risks and regulatory deficiencies.
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Documentation Updates –
Updating CTD, ACTD, DMF and supporting
regulatory documents whenever changes occur.
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Authority Query Management –
Preparation of responses to health authority
questions, observations and deficiency letters.
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Global Lifecycle Support –
Regulatory maintenance support for domestic
and international markets.