DJA GLOBAL PHARMACEUTICALS, INC. SERVICES

DJA Global Pharmaceuticals, Inc. is a Global Regulatory Consultant to the Pharmaceutical, Device & Biotechnology Industries, with associates in Europe and Canada.

[PLEASE NOTE: DJA will not assist with any products that involve whole blood or its components (red blood cells, white blood cells, platelets or plasma) or embryonic stem cells.]

Global Regulatory Document Preparation & Maintenance

• EU & Canadian DMFs, INDs, NDAs, ANDAs, MAAs, NDSs, Amendments and Variations.

• Global Regulatory Guidance for Ensuring Timely Approval of Clinical Trial and Marketing Applications.

• Global Regulatory Agents for Various Products and Intermediates.

• Document Preparation, Formatting & Publishing.

• eCTD Submission Preparation and Publishing to meet regulatory agency and ICH requirements.
  

Global Regulatory Strategy Development & Agency Meetings

• Scientific & Regulatory Guidance on Development and Registration Issues.

• Preparation for Global Agency Meetings.

• Resolution of Issues Relating to Drug Substance, Drug Product, Excipients & Raw Materials.

• Scientific and Regulatory Guidance on Chemistry, Manufacturing, & Control (CMC)

• Development & Implementation of Global Strategies for Addressing TSE/BSE Issues.

• Development & Implementation of Internal Compliance Systems/Processes.

• Scientific & Regulatory Assessment of Information for In-license Compounds.

Preparation for FDA & EU Agency Inspections

• Preparation for Pre-Approval Inspections.

• cGMP, GLP and GCP Guidance and Implementation.

Training

• Customized Global Regulatory In-house Workshops, Seminars and Training Courses.

WHAT WE OFFER:

• Exceptional team of pharmaceutical development and global regulatory experts with significant prior experience from major and small pharmaceutical companies.

• Significant hands-on experience in problem-solving for small and large companies.

• Significant scientific background.

• Timely and detailed attention to project needs and objectives.

• Confidentiality

EXECUTIVE STATEMENT

DJA Global Pharmaceuticals is focused on bridging the complex areas of pharmaceutical development and global regulatory science. DJA was founded to provide sound, practical guidance to the pharmaceutical, device, and biotechnology industries. DJA is composed of highly technical and experienced consultants that are dedicated to applying the highest standards of regulatory rigor, ethics, and professionalism. Our consultants have significant industry and global regulatory expertise to resolve challenging issues.

Based on our proven track record of success we believe the key factors to successful product development and commercialization include the following:

• Understanding customer project needs and objectives.

• Proactive integration of strategic regulatory direction to your project objectives right from the beginning.

• Providing sound, strategic solutions to meet the challenges that are typical of development and global regulatory affairs.

• Providing timely, cost-effective services based on real-life experiences.

We accomplish this by assisting our clients in meeting project objectives and deadlines without sacrificing integrity, innovation, or excellence.

We also offer various in-house and off-site training to meet the needs of our clients.

By choosing DJA to fulfill your development and global regulatory needs, you will be selecting a company with a combined experience of well over 100 years that will effectively manage your project with success!

Damaris DeGraft-Johnson, RPh, MSc. Med. Chem.
Founder and President