The regulatory approval process can be daunting for even the most seasoned team and well-planned project. With great reason, regulatory authorities are placing value in clinical trials that have comprehensive safety infrastructures. Clindataceutics’s Strategic Regulatory team is your end-to-end solution for navigating regulatory processes throughout your product’s life cycle.
Regulatory affairs are another core area for clinical trials. Pharmaceutical firms need a constant update on in-and-out on country-specific regulatory and ethics requirements to keep compliant with ever-changing legislation.
GVR BIO SCIENCE CRO understands the value of offering their clients access to international biopharmaceutical industry experts. One of the primary objectives of Pepgra CRO is to enable their clients to achieve their enterprise goals through increased product value and cost-effectiveness
You can focus on bringing new treatments to patients when you trust our Strategic Regulatory team to navigate the ever-changing regulatory environment for you..
We deliver unparalleled expertise. We act as your liaison in all interactions with regulatory agencies from regulatory strategies to providing regulatory submission support to achieve your marketing objectives.
Clinical trial authorizations (CTA)
Competent authority meetings
Due diligence
IND/IDE/BLA applications
Local representative.
Pediatric investigation plans (PIP)
Product labeling.
Reimbursement (CRO).
Safety risk minimization plans ,Scientific advice, protocol assistance