Regulatory Submission

Drug Master File:

Drug Master File (DMF) is a submission of information to the FDA to permit the FDA to review this information in support of a third party’s submission without revealing the information to the third party.

DMFs usually cover the Chemistry, Manufacturing and Controls (CMC) of a component of a drug product e.g. drug substance, excipient, packaging material.

Drug product information or non-CMC information may be filed in a DMF.

The directory structure is a structure of directories and files. There should be a reasonable maximum number of entries (directories and files) per directory. The directory structure should follow the rules below. The files could be in several formats as specified of below.

Each of our teams is designed, equipped and operated to deliver high quality filing with defined cost and submission schedules (CBE, PAS, Supplemental NDA). Our team has flexibility to get approval for wide range of dosage forms and into the global markets. We are also open to collaborate for our manufacturing facilities as per the requirements of our customers. For further information please contact our Business Development team.

We provide world class regulatory which operate under global regulatory and safety standards. We work on cost-effective development and regulatory approval tapping globally competitive infrastructure and technology by an efficient team of data scientists.

With our expertise in formulating innovative and affordable dosage forms, we have embarked the path of going global by custom regulatory filing for reputed clients to various regulated markets across the globe.

• Strategic, global approach to regulatory planning and product development
• Global network of regulatory affairs experts with local knowledge
• Expertise in a wide range of therapeutic categories
•  Proven track record of success with regulatory approvals with country specific health authorities
• Coordinated and focused compliance throughout the product lifecycle

Regulatory Filing in e-CTD format (Electronic Common Technical Document) to major regulatory and health authorities.

1. USFDA
2. EUGMP
3. TGA
4. PMDA
5. KFDA 

Dossier Authoring Services
Regulatory submission CMC writing including

• Investigational new drug applications (e.g., IND / INPD / CTA)
• Marketing authorization applications (e.g., NDA / MAA / NDS)
• Generic drug applications (e.g., ANDA / ANDS)
• Biologics license applications (e.g., BLA)
• Drug Master Files
• Global expansion filing support documents for ROW submissions
• Lifecycle submissions such as variations (e.g., CBE-0 / CBE-30 / PAS / sANDS), annual reports, renewals

Regulatory Support and Advice

• Define regulatory requirements and recommendations for new products,
• regulatory filing strategies and post-approval changes
• Regulatory review of QbD (Quality by Design) / QbR (Question based Review)
• CMC Module 3 gap assessment (product development and existing application)
• CMC Module 3 pre-submission dossier review

Regulatory Publishing
Full publishing services available for FDA, EU and MHRA and many other international Health Authorities

• eCTD and non-eCTD electronic submissions
• Collation and compilation of complete dossiers Module 1 through 5
• Submission to Health Authorities via electronic gateways

Health Authority Meetings
Prepare correspondence documents and participate in pivotal meetings with health authorities for  development projects and life cycle management across the product development timeline.

Clinical Support and Clinical Labelling

• Labeling assistance for clinical trial material (test and reference)
• Regulatory label review for US, EU, Canada, Australia, Asia Pacific and Latin America
• Translation and back-translation coordination

Quality Management Systems

• Conforming to the international standards,
• Use of Best-in-Class technologies
• Implemeting roboust Quality Management System by contious education and training,
• Consistently meeting appropriate technical, regulatory and legal requirements.