CMC-Regulatory Affairs

CapEval Pharma provides advice and guidance aimed at addressing regulatory challenges encountered during the drug development process. We help our customers manage the risks associated with product development evaluating both the scientific and regulatory issues that will impact their programs and we develop strategies for a successful regulatory submission.

Services Offered:

• Regulatory support for pharmaceutical development services specfically in the area of manufacturing, controls and analytical chemistry

• Development, preparation and assembly of CMC dossiers for Europe and USA

• Preparation of responses to regulatory authorities, comment letters, and assessment reports for CMC related issues

• Preparation of briefing documents

• Gap analysis of CMC regulatory submission including recommendations to facilitate the review of applications by regulatory authorities

• Assistance in responding to compliance issues

• Preparation of Type II DMFs, reactivations, amendments and annual reports

• Setting and establishing appropriate specifications based on process understanding and toxicology qualification limits

• Developing appropriate specifications for starting materials to ensure production of API which meets all necessary quality attributes

• Review of methods and validation reports to ensure regulatory compliance

Regulatory Due Diligence

Regulatory due diligence can be undertaken for in- and out- licensing opportunities. We can evaluate reports and documentation for regulatory compliance in the area of chemistry, manufacturing and analytical controls and provide an expert review including for example: key questions, gaps in manufacturing and controls, assessment of regulatory risk and strategy.

Resolving Regulatory Questions

Our approach to the drug development process means we are well equipped to respond to questions raised by regulatory agencies. We can interact with regulatory agency personnel to ensure agency and sponsor understanding of CMC, regulatory and non-clinical development data.

Product Development

A strong regulatory strategy relies on identifying phase appropriate requirements to ensure the quality, safety, and efficacy of the drug. Appropriate controls have to be identified and implemented before, during and after production and testing acceptance criterion have to be met. Documentation must be traceable, legible, accurate and detailed and include conclusive analyses and results.  To ensure success in this area, we can work with you at the start of product development or manage the process in its entirety, from supply of clinical trial material onwards.

We Can Assist With:

• Contractor selection for chemical synthesis and analytical development

• Supplier qualification and audits

• Technology transfer to manufacturing scale and supervision to ensure GMP compliance

• CMC project management

• Implementation of regulatory strategy and controls, generation of correct, accurate documentation following this strategy to be used for regulatory submission