Services
Medical Writing
Our skilled medical writers craft clear, precise, and compliant documents tailored to your needs, including:
- Clinical Study Protocols
- Clinical Study Reports (CSRs)
- Investigator’s Brochure (IB)
- Developmental Safety Update Reports (DSUR)
- Periodic Benefit-Risk Evaluation Report (PBRER)
- Regulatory Submissions
- Scientific Publications.
Medical Devices
Our team of experienced medical writers specializes in creating high-quality clinical documents for MEDICAL DEVICES
- Biological Evaluation Plan (BEP)
- Biological Evaluation Report (BER)
- Biological Risk Assessment (BRA)
- Post Marketing Clinical Follow-up Plan/Report (PMCF)
- Clinical Evaluation Plan/Report (CER)
- Regulatory Submissions
- Scientific Publications.
Regulatory Affairs
Understanding and adhering to regulatory requirements is crucial for success in the healthcare industry. Our regulatory affairs specialists provide strategic guidance and support throughout the product lifecycle, helping you secure approvals and maintain compliance.
Clinical Development
Our team of experienced professionals collaborates closely with clients to ensure that clinical trials are conducted efficiently, ethically, and in compliance with regulatory standards. With a focus on quality and innovation, we leverage the latest methodologies and technologies to optimize study outcomes and accelerate the path to market. Whether you're embarking on early-phase trials or need assistance with post-marketing studies, our dedicated services are tailored to meet your unique needs and drive your success in bringing safe and effective therapies to patients.
Non-Clinical Services
Our comprehensive non-clinical services cover a wide range of areas, including safety assessments, pharmacology, and environmental impact evaluations. We leverage our expertise to provide thorough, data-driven insights that inform your decision-making.
- Study Plans & Reports in compliance to GLP
- Studies in compliance with GLP
- Studies Compliance with NDCT/Schedule-Y, ISO 109903 (ISO 17025) and OECD
- Histopathology Services
PDE and ADE
We specialize in safety assessments that define Permitted Daily Exposition (PDE) and Acceptable Daily Exposure (ADE), ensuring that pharmaceuticals and chemicals meet stringent safety standards to protect public health.
OECD GLP QAU
Our team of experienced technical experts are specialized in creating high-quality documents for submissions in compliance to OECD DLP
- Expert team to establish QA System for new establishment
- Auditing current or exiting GLP facilities
- Auditing services for GLP Studies
- Auditing services for GLP Data and Study Reports
- Study Plans & Reports in compliance to GLP
Occupation Exposure Limits (OEL)
We provide expert guidance on Occupational Exposure Limits (OEL), helping organizations establish safe exposure levels for hazardous substances in the workplace to protect employee health and ensure compliance with regulatory standards.
