Diallo Global Regulatory CMC Consulting provides the expertise necessary to deliver quality Chemistry, Manufacturing, and Controls regulatory dossiers that expedite product approvals.

Regulatory strategy consultation and planning

Diallo Global Regulatory CMC Consulting provides strategic, regulatory, and scientific planning for post-approval variations.

¤  Strategic CMC regulatory advice. 

¤  Identification of CMC information appropriate for regulatory dossiers including:
   - Determination of Suitable Analytical Specifications
   - Method Validation Evaluation Parameters 
   - Minimum Stability Data Requirements 

¤  Gap analysis of available CMC information. 

¤  Evaluation of proposed manufacture and controls changes for dossier impact. 

¤  Evaluation of CMC Regulatory capability of potential contract manufacturing facilities. 

¤  Liaise between your Company and Contract Service Providers on CMC issues impacting product registration.

Development, preparation, and review of CMC documentation

Diallo Global Regulatory CMC Consulting prepares CMC documentation using Common Technical Document (CTD) and electronic CTD (eCTD) Formats.

Preparation of CMC submissions for post-approval variations & DMFs.

Prepares and reviews the following dossiers and sections:

  - Dossiers

¤  Post-approval Amendments, Supplemental NDA and MAA Variations 

¤  Deficiency Letter Responses 

¤  Annual Reports 

¤  Drug Master Files (DMF) 

¤  GMP Statements 

¤  Drug and Establishment Listing 

 - Sections

¤  Quality Overall Summary 

¤  Drug Substance 

¤  Drug Product

¤  Environment Assessment Categorical Exclusion

¤  Methods Validation 

¤  Validation of Sterilization Process 

Provides documents as:

¤  Hard copies (Word and PDF files) Paper copies 

¤  Electronic files (eCTD, CD, Hypertext Link)

 

Regulatory agency interactions

Communication and negotiations with Regulatory Agencies are important for any Development Program. Diallo Global CMC Consulting has experience interacting with CMC reviewers, including the following:

¤  Effective negotiations with Regulatory Authorities. 

¤  May interact directly with Health Authorities as client's agent on CMC related issues.

CTD Template and regulatory guidance for technical documents submissions 

Regulatory documentation must be complete and of consistent quality.

Diallo Global CMC Consulting will prepare customized CMC dossier and technical document templates.

In addition, customized corresponding Regulatory Guides which provide author instruction for document contents may be prepared."

CMC Regulatory requirements for investigational, marketing, and post-approval submissions.

Coordination activities

Diallo Global Regulatory CMC Consulting can act as coordinator for other regulatory activities for your company including:

¤  cGMP Compliance and Inspection assistance. 

¤  Process validation. 

¤  Preparation of electronic submissions. 

¤  Pharmaceutical and Analytical development strategies. 

¤  Development of regulatory training programs.

Excellence in Biopharmaceutical Regulatory Strategy and Planning