The regulatory group is comprised of professionals from the industry and health authorities with proven track records of getting regulatory approvals of NDA, BLA, ANDA and MAA. PharmaServ provides solutions to your regulatory needs, problems or issues. Our regulatory expertise includes worldwide regulatory and development strategy, technical writing, submission related services, technical assistance and training.
PharmaServ offers a various mission-critical services to the regulated industry. Our scientific, technical and compliance experts are veterans of the Industry, and are capable of assisting you to resolve your most challenging issues. Our proficiency is based on the optimal integration of scientific, technical and regulatory principles. We work with our clients to design and implement effective and efficient processes that assure continued compliance. We help our clients stay current with the ever-changing regulatory environment. Our regulatory compliance services include quality systems design and evaluation, audits, compliance assessment and problem resolution, and training programs.
Our clinical, pharmacokinetic, non-clinical and CMC experts provides guidance on development of drugs and biologics, specifically in clinical, PK and toxicology study design, CMC development strategy, and bioanalytical method development. In addition, our services include bioequivalence and bioavailability study designs, preparation of study protocols and preparation of study reports. We also provide complete statistical and data management support.
Pharmacovigilance is a critical component for determining the benefit to risk ratio of treatment. The potential for drug toxicity is determined throughout the lifetime of use of a drug or biological agent, including the development cycle.
To download a brochure on our capabilities, please click here. For details on the team of experts, please click here