Regulatory Affairs Services

Dossier Compilation & Regulatory Submissions

CPPL specializes in the preparation, review, and compilation of Common Technical Documents (CTD) and electronic CTDs (eCTD) for submission to regulatory authorities across multiple global markets.

This includes both regulated (EU, Canada, UK, Australia) and semi-regulated (Asia, Africa, Latin America, CIS) regions.

The dossier services cover:

• 1. Module-wise CTD/eCTD preparation
• 2. Product registration files (new drugs, generics, fixed-dose combinations)
• 3. Country-specific adaptations as per ICH guidelines
• 4. Life-cycle management (variation filing, renewals, responses to queries)

With over 6,000 successful dossier compilations, CPPL has built a comprehensive and efficient documentation process that integrates regulatory expectations with technical data, ensuring faster approvals and reduced risk of rejection.

Drug Master File (DMF) Preparation & Filing

CPPL supports the development, formatting, and submission of Drug Master Files (DMFs), including:

• 1. Type I to Type IV DMFs
• 2. Active Pharmaceutical Ingredients (API)
• 3. Excipients, Packaging Materials, and Intermediates
• 4. Open and Closed Part structuring

The service includes end-to-end coordination with manufacturers, technical writing, regulatory compliance checks, and support during agency evaluations or audits.

Advanced Regulatory Services

CPPL has aligned its systems and team with current global regulatory developments, including:

• 1. Evolving ICH guidelines
• 2. Country-specific variations in dossier format
• 3. PIC/S-compliant documentation
• 4. Risk-based quality assessments
• 5. Responses to regulatory authority queries and deficiency letters
• 6. GDUFA and ANDA submission support (where applicable)

CPPL remains continuously updated with changing requirements and provides timely advisory services and documentation updates.

Regulatory Intelligence & Market Access Support

In addition to documentation, CPPL provides:

• 1. Regulatory gap assessments
• 2. Market-specific submission strategy
• 3. Technical due diligence for product in-licensing or out-licensing
• 4. Labeling and artwork review per regulatory norms
• 5. Compilation of Site Master Files (SMF) and Product Development Reports (PDRs)

Why Cyclone Pharmaceuticals Pvt. Ltd. for Regulatory Affairs?

With a track record of more than 6,000 successful dossiers compiled and submitted, CPPL is considered one of India’s most experienced and dependable partners in pharmaceutical regulatory consulting.

The company’s in-depth regulatory understanding, document accuracy, and compliance-oriented approach make it a preferred service provider for manufacturers seeking to expand into global markets.