SERVICES

SERVICES

CMC and analytical development consulting meetings can be scheduled, as needed, or on a regular and recurring basis. 


  • Development Strategy

A well-thought-out CMC development strategy is essential to remaining competitive and meeting accelerated timelines. We have experience in bringing a highly complex small molecule such as Halaven, containing 19 stereogenic centers and made by a 62-step total synthesis, through clinical development and commercialization. We also have experience with large molecules, such as the 58 kD fusion protein, Ontak.

  • Regulatory Feedback

Having clear, concise, well-written responses to regulatory inquiries helps ensure smooth development. We have extensive experience in answering questions from global regulatory authorities, and we advise and assist clients in this area. 

  • Problem Solving & Analytical Technology Issues

As structural complexity increases with development candidates and certain molecular features make production and analysis challenging, firms are likely to face analytical problems. We have experience developing analytical methods for complex molecules which pose interesting challenges. 

CMC Report Authoring & Reviewing

CMC studies are documented in reports which serve as the foundation from which regulatory filings are authored. It is essential, and required by law, to accurately and clearly document the studies conducted during pharmaceutical development. We have years of experience in producing essential CMC reports from which Module 3 (Quality) is derived. Some of those reports include, for example, the following:



  • Analytical Test Method Reports, Validation Protocols, and Validation Reports
  • Physical and Chemical Characterization Study Reports
  • Spectroscopic Chemical Structure Analysis Reports
  • Spike, Fate, and Purge Study Reports
  • Specifications Justification Reports
  • Control Strategy Reports
  • Stability Reports


CMC Report Authoring & Reviewing

CMC studies are documented in reports which serve as the foundation from which regulatory filings are authored. It is essential, and required by law, to accurately and clearly document the studies conducted during pharmaceutical development. We have years of experience in producing essential CMC reports from which Module 3 (Quality) is derived. Some of those reports include, for example, the following:



  • Analytical Test Method Reports, Validation Protocols, and Validation Reports
  • Physical and Chemical Characterization Study Reports
  • Spectroscopic Chemical Structure Analysis Reports
  • Spike, Fate, and Purge Study Reports
  • Specifications Justification Reports
  • Control Strategy Reports
  • Stability Reports


CMO & CRO Management

Many biotech and pharmaceutical firms rely upon contract manufacturing organizations (CMOs) to support their CMC development and clinical supply activities. Identifying the right CMO and working with them, productively, has a major influence on smooth and successful CMC development. We have years of experience working with CMOs and CROs (contract research organizations). A sample of our typical services includes:


  • Review of CMO & CRO Capabilities
  • Participation in Regular Meetings
  • Reviews of CMC Reports
  • Problem Solving

Regulatory Filing Authoring & Reviewing

We have a significant amount of experience in authoring and reviewing regulatory filings. We also have experience interacting with regulatory agencies via phone conference, face-to-face meeting, as well as FDA pre-approval inspection. A list of our regulatory document authoring and reviewing experience includes:



  • INDs, NDAs, BLAs, IMPDs, and MAAs
  • End-of-Phase 2 Briefing Documents
  • Responses to Regulatory Questions

Regulatory Filing Authoring & Reviewing

We have a significant amount of experience in authoring and reviewing regulatory filings. We also have experience interacting with regulatory agencies via phone conference, face-to-face meeting, as well as FDA pre-approval inspection. A list of our regulatory document authoring and reviewing experience includes:



  • INDs, NDAs, BLAs, IMPDs, and MAAs
  • End-of-Phase 2 Briefing Documents
  • Responses to Regulatory Questions

Document QC Reviewing

Data integrity has been a prime area of focus for regulatory agencies in recent years. A tremendous amount of data and information go into CMC reports and regulatory filings. We have significant experience in conducting Quality Control reviews of Analytical and CMC reports as well as Quality Control reviews of regulatory filings which include INDs and NDAs.  

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