Regulatory Affairs Service And Consultancy
The regulatory environment of the global healthcare industry is a continuously evolving forum to support the scientific developments and global awareness of the exacting standards required in order obtain global licensing. Chiltern’s regulatory department tracks all national legislation, draft legislation, guidelines and judicial decisions in their efforts to provide a proactive research program for their clients.
Chiltern Global Regulatory Team consists of professional scientists covering all scientific disciplines with a collective industry experience of more than 300 years. The global reach of these professions is sited in Asia Pacific, Europe, Latin America and North America.
The following are the core services that we provide:
Expert regulatory consultancy
- Providing immediate desk top regulatory consultancy
- Regulatory and technical due diligence
- Preparation, submission and management of pediatric investigation plan, modifications or waivers.
- Preparation, submission and management of requests for scientific advice / protocol assistance.
- Development of safety risk minimization plans.
- Regulatory training.
- Therapeutic consultancy.
Clinical trials
- Preparation, submission and maintenance of Clinical Trial Authorizations (CTA) for Phase I – IV trials for drugs and devices.
- Preparation, submission and management of IND applications to the FDA.
- Assessment of data for suitability for CTAs / registration.
All elements of product development, licensing strategies and marketing authorizations.