Services

Documentation, SOPs & Compliance

We help healthcare organizations establish robust documentation frameworks, standardized SOPs, and strong compliance governance that support sustainable growth and regulatory confidence. Our services ensure that products, brands, and promotional activities are backed by accurate scientific documentation, clear PMT processes, and audit-ready systems.

 

Through compliance reviews, brand audits, and regulatory alignment, we strengthen operational discipline, risk management, and long-term brand credibility.

Our Capabilities

Audit-ready processes through compliant documentation

Product Monographs

We create comprehensive, up-to-date product monographs serving as the central scientific reference for brands. Each monograph integrates composition, MOA, indications, dosage, safety, clinical evidence, contraindications, and references, ensuring consistency across marketing, medical, and regulatory teams.

Scientific Documentation

We develop structured scientific and technical documentation, including literature review summaries, claim substantiation dossiers, evidence compendiums, internal medical briefs, and competitive scientific comparisons. All deliverables follow strict traceability, version control, and audit-readiness standards.

PMT SOPs & Launch Checklists

We design end-to-end SOPs for Product Management Teams covering molecule evaluation, brand creation workflows, launch planning, and post-launch lifecycle management. Our structured launch checklists ensure cross-functional alignment and minimize execution risk.

Brand Registration Support

We provide end-to-end coordination support for brand registration, including documentation preparation, timeline tracking, and follow-ups helping minimize delays and rework.

Trademark & IP Guidance

We offer strategic guidance on trademark and intellectual property considerations, supporting name screening, classification understanding, and coordination with legal partners to protect brand equity.

Periodic Brand Audits

Our structured brand audits assess scientific claim accuracy, promotional compliance, label and pack consistency, pricing and positioning alignment, and field communication practices. Findings are converted into clear corrective and preventive action (CAPA) recommendations.

Compliance Reviews (FSSAI / CDSCO)

We conduct systematic compliance reviews of labels, promotional materials, digital content, and claims against FSSAI, CDSCO, and applicable guidelines, helping organizations stay inspection ready.

Why Clients Rely on Us

Audit-ready processes through compliant documentation

01

Deep understanding of Indian healthcare regulations

02

Practical, business-aligned compliance solutions

03

Reduced regulatory risk and faster execution

04

Scalable frameworks supporting portfolio growth

05

Organizations professionalizing PMT and compliance processes

06

Brands operating across multiple regulatory categories

Let's Drive Better Healthcare Outcomes

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