Our Core Areas of Expertise

Regulatory Compliance & GMP Audits

We conduct comprehensive GMP audits and compliance assessments based on global regulatory frameworks such as:

• 1. PIC/S
• 2. USFDA
• 3. EU-GMP
• 4. WHO-GMP

Our audits evaluate manufacturing operations, Quality Management Systems (QMS), documentation practices, and readiness for inspections. This helps pharmaceutical companies identify regulatory gaps and prepare for successful approvals and inspections.

GMP & Regulatory Training Programs

Cyclone Pharmaceuticals offers structured and customized training sessions on:

• 1. Current Good Manufacturing Practices (cGMP)
• 2. PIC/S Guidelines
• 3. Data Integrity & Quality Assurance
• 4. Audit & Inspection Preparedness

These trainings are designed for operational, quality assurance, and regulatory personnel, and are regularly updated to reflect current regulatory expectations.

Dossier Preparation & Submission Support

We provide complete support for CTD and eCTD dossier preparation for product registration in both regulated and semi-regulated markets. Our dossier services include:

• 1. Module-wise document drafting and compilation
• 2. Country-specific adaptations
• 3. Review and formatting as per ICH guidelines

Drug Master File (DMF) Services

Our team assists in the preparation and maintenance of Drug Master Files (DMFs), including:

• 1. Type I – IV DMFs
• 2. API, excipient, packaging material documentation
• 3. Open and closed part structuring
• 4. Submission support aligned with international guidelines

Documentation & Tech Transfer Support

We support the preparation of critical technical and regulatory documents, including:

• 1. Standard Operating Procedures (SOPs)
• 2. Validation Protocols (Process, Cleaning, Analytical, etc.)
• 3. Technology Transfer Documentation

These documents are aligned with regulatory and technical expectations for smooth audits, approvals, and product scale-up.

A Trusted Technical & Regulatory Partner

Cyclone Pharmaceuticals Pvt. Ltd. serves as a reliable partner for pharmaceutical companies looking to maintain, improve, and demonstrate compliance with global regulatory standards. With experience across various dosage forms and markets, our services are tailored to meet the unique requirements of clients across the pharmaceutical value chain.