Dossiers, Registration & CMC - Regulatory Affairs

Dossiers and Registrations

Regulatory Documentation

IMPD, IB, IND, NDA, CTA, EC,
CTD
Quality Overall Summary reports
Briefing Packages for regulatory authorities
Expert reports and statements
Replies to regulatory authorities
REACH files

International Dossiers

Registration for pharmaceuticals (NCE’s, biologicals, vaccines, diagnostic tools and medical devices), veterinary drugs
Registration for agrochemicals
Notification for chemicals
Technical dossier of information for cosmetics
IMPD, IND and Overall Quality Summary reports for clinical trial applications

Registration

Expert reports
Follow-up and discussions with appropriate competent authorities

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.

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.

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