FDA Regulatory Strategy and eCDT Publishing 

Regulatory Strategy

What we do

We define the right regulatory path and get you ready for submission.

• Gap analysis of your current program

• Regulatory strategy for FDA and global markets

• Indication and label positioning

• Clinical and protocol alignment

• CMC guidance (stability, API, manufacturing changes)

• Regulatory intelligence to support decisions

Who it’s for

• Biotech startups preparing for IND or first FDA interaction

• Small pharma teams without senior regulatory leadership

• Programs at risk of delay, rejection, or misalignment

Outcome

• Clear regulatory pathway

• Defined indication and labeling strategy

• Submission-ready plan with timelines

• Reduced risk of FDA pushback

Timeline

• Gap analysis: 1–2 weeks

• Full strategy: 2–4 weeks

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eCTD Publishing Services

What we do

We prepare, validate, and submit your electronic regulatory filings accurately and on time.

• Document formatting and editing

• Hyperlinking and QC verification

• Initial submissions: IND, NDA, ANDA, BLA, eDMF

• Amendments and supplements

• Secure submission via FDA Gateway

• Cloud-based portal for tracking and archival

Who it’s for

• Teams require additional publishing expertise

• Sponsors facing complex submission requirements

• Companies seeking faster, error-free eCTD submissions

• Looking for a lower cost compared to quality work

Outcome

• Submission-ready eCTD dossiers

• Reduced technical rejection risk

• Single point of contact for seamless coordination

• Fully compliant with FDA 21 CFR Part 11

Timeline

• Small submissions: 1–2 weeks

• Full dossiers: depends on document readiness

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