Intrinsic knowledge of the regulatory environment and extensive interaction with the health authorities has enabled Metrics Research provide essential regulatory support to its clients. Our team includes committed regulatory affairs consultants having extensive experience in regulatory submissions and approvals in Pakistan and neighboring countries. Metric Research has gained extensive knowledge and experience through direct interaction with the health authorities. We act as service providers for our clients for regulatory dossiers, safety reports and clinical trial reports submissions on an ongoing basis.
We also offer results oriented solutions in preparing and defending regulatory submissions.
Metric Research’s regulatory services include;
Clinical Trials Regulatory Approvals
- Development, compilation and submissions of clinical trial applications
- CTA submission meeting regulatory requirements for specific countries in South Asian region such as Bangladesh, Afghanistan and Sri Lanka among others.
Pharmaceutical Products Registration
- Consultation services
- Preparation /review of dossiers/ applications
- Bridging studies (“builds a bridge” between the information available from the tests already performed and the questions arising from new conditions. BS are also done when there is a change in the manufacturing process or the packaging, storage, dosage or other changes that might affect the safety, effectiveness or stability of the medication).
- Report summarizations for submissions