Regulatory Experience:
The Metric Research team includes regulatory affairs professionals who have experience of regulatory submissions in Pakistan and other neighboring countries. The team is thus able to provide regulatory consultation and create and defend regulatory submissions of all kinds of pharmaceuticals.
Consult, Create, Defend Regulatory Submissions:
Intrinsic knowledge of the regulatory environment allows Metric Research to provide essential regulatory support to its clients.
Metric Research’s regulatory review and support includes services, such as:
- Consultation and planning
- Preparation/review of dossiers/application
- Bridging studies
- Report summarizations for submissions
Metric Research has extensive experience in interacting directly with the regulatory authorities. We have acted as agents for customers with the regulatory authorities, submitted regulatory dossiers, safety reports and clinical trial reports, met with experts and made presentations to regulatory agencies on behalf of the customer.
Metric Research' regulatory affairs professionals provide the following services in support of clinical trials:
- Development, compilation and submissions of clinical trial applications for regulatory authorities
- Regulatory requirements for specific countries and regions
- CRF design and preparation
Consultancy in Regulatory Compliance and Retainer ship Services:
Metric Research helps its customers to comply with the local regulatory requirements. We keep check of the existing regulations as well as changes in requirements. We provide assistance to our customers in resolving any regulatory issue or non-compliance etc. These services are available for our member clients on retainer ship basis.
We can assist with product labeling requirements and perform regulatory GAP analysis.
Molecule Search, Licensing-In and Out support:
Metric Research helps its clients to search molecules or pharmaceutical products from different sources around the world. We have sourcing agents in China, Korea, Argentina, UK and USA etc., who help us to find out the suitable molecules required by our customers.
Translation:
Metrics Research has access to excellent translating services in academic institutes ensuring a fast turnaround time for clinical trial documents, ranging from patient information consent to Investigator's Brochures. The translation process is coordinated by experienced personnel with medical/ pharmacy expertise to ensure accuracy and consistency in content and style. Translation services are available for all major Pakistani languages internally as well as foreign languages such as French, German, Spanish and Chinese via collaborative partners in a time- and cost-competitive manner.
