Services

Research Services

In today's rapidly evolving scientific landscape, research services play a pivotal role in enabling breakthroughs and innovation across various fields. Our comprehensive research services encompass a wide spectrum of cutting-edge capabilities to support your scientific endeavours. In the realm of Bioanalytic Services, our expert team utilizes state-of-the-art instrumentation and techniques to analyse complex biological samples with precision and accuracy, providing valuable insights into biomolecular structures and interactions. Our Molecular Biology Services offer a robust suite of tools for genetic analysis, including DNA sequencing, PCR, and gene expression studies, enabling you to unravel the intricacies of genetics and genomics. With our Flow Cytometry services, we empower you to delve into cell characterization and sorting, offering unparalleled insights into cellular functions and population dynamics. Additionally, our R&D Services provide a collaborative platform for innovation, fostering the development of novel techniques and solutions tailored to your unique research needs. Whether you are exploring the frontiers of biological sciences or seeking to advance your research goals, our integrated services are designed to drive scientific excellence and discovery.

SEND Services

The Standard for Exchange of Nonclinical Data (SEND) is an implementation of the CDISC Standard Data Tabulation Model (SDTM) for nonclinical studies. SEND provides a standard format for presenting nonclinical data, ensuring consistency in the organization and integration of study information. This facilitates the process of submitting nonclinical data to regulatory bodies, leading to greater coherence in presentation and transparency in the assessment and analysis of the information. Ultimately, SEND enables a more efficient and streamlined journey towards regulatory approval.

SENDIG's Core Focus: Designed for various study types, including:

  • Single-dose general toxicology
  • Repeat-dose general toxicology
  • Carcinogenicity studies
  • Respiratory and cardiovascular testing in safety pharmacology studies.

Diverse Study Support: Additional SENDIG versions cater to specific study types:

  • SENDIG-DART v1.1 and 1.2: Focuses on DART studies, particularly embryo- fetal development and juvenile animaltoxicity.
  • SENDIG-AR v1.0: Supports data submission under the Animal Rule.

Ensuring Conformance and Quality:

  • Conformance rules ensure generated data structures conform to standards.
  • These rules identify and codify conformance criteria and case logic
  • Supports development of quality processes and tools for data integrity.

Toxicology Safety and Risk Assessment

Toxicology safety and risk assessment play a pivotal role in safeguarding public health and the environment. Over the years, we have provided invaluable support to various industries, including pharmaceuticals, manufacturing, toy production, and aerospace. Our expertise lies in delivering comprehensive safety and risk assessment reports that encompass a wide range of critical parameters, including Hazard-Based Exposure Limits (HBEL), Permitted Daily Exposure (PDE), Occupational Exposure Limits (OEL), Medical Device Regulation (MDR) compliance, Electronic Common Technical Document (eCTD) submissions, and In Vitro Diagnostic Regulation (IVDR) compliance. Our commitment to delivering high-quality assessments has made us a trusted partner in ensuring the safety and regulatory compliance of our clients across these diverse sectors.

Regulatory Toxicology and Risk Assessment Services :


Cleaning Validation and Occupational Health

  1. Permitted Daily Exposure (PDE) / Acceptable Daily Exposure (ADE)
  2. Occupational Exposure Limit (OEL)
  3. Occupational Exposure Banding (OEB) / Occupational Health Categorisation (OHC)

Pharmaceuticals

  1. Impurities qualification as per ICHQ3A / ICHQ3B
  2. Elemental impurity assessment as per ICHQ3D
  3. Impurity assessment for residual solvent as per ICHQ3C
  4. Genotox assessment of impurities (In-silico / Literature) as per ICHM7
  5. Nitrosamine risk assessment / Cohort of concerns as per USFDA & EMEA
  6. Excipient evaluation and justification for the proposed limit
  7. Extractable and Leachable (E&L) toxicology risk assessment

Dossiers Compilation

  1. CTD dossiers compilation
  2. eCTD dossiers compilation
  3. Annual report compilation:
    • Periodic Safety Update Report
    • (PSUR), Drug Safety Update Report (DSUR)
    • Addendum to Clinical Overview (ACO)
    • New Drug Application (NDA)
  4. Product Information Leaflet (PIL)
  5. Compilation of Drug Master File (DMF) - Open & Restricted Part

Cosmetics

  1. Cosmetic Product Safety Report (CPSR) as per SCCS & EU Regulations
  2. Product Information File (PIF) as per SCCS & EU Regulations
  3. Exposure calculations for INCI
  4. Fragrance and flavours assessment

Medical Device

  1. Biological Evaluation Plan (BEP) and Biological Evaluation Report (BER) as per EU MDR 2017/745 & ISO 10993
  2. Toxicological Risk Assessment (TRA) as per ISO 10993-17
  3. Gap assessment as per EU MDR 2017/745 & ISO 10993
  4. Designing of biocompatibility studies as per ISO 10993 & ISO 18562
  5. Risk Management Plan (RMP) as per ISO 14971

Agri and Consumer Products

  1. Pesticide Risk Assessment / Maximum Residual Levels (MRL) as per USEPA
  2. Food contact materials / Food additive evaluation
  3. Toxicological evaluation of consumer products
  4. Exposure assessment of consumer products

Others

  1. Toxicological risk assessment for toys as per EU Directive 2009/48/EC
  2. MSDS as per REACH & OSHA
  3. In-Silico predications
  4. Literature search and data mining
  5. Tox Profile
  6. Recommendation & monitoring of preclinical and analytical CROs

Clinical Services (Bioequivalence/Bioavailability Studies)

  1. Management of Bioequivalence / Bioavailability Studies
  2. CRO identification in India, budgeting, negotiation, and contract preparation
  3. Pre study initiation Audit of the CRO
  4. Management of Investigational Medicinal Products (IMPs)
  5. Monitoring of study on behalf of the sponsor
  6. Monitoring of bioanalytical analysis on behalf of the sponsor
  7. Supporting the regulatory audit on behalf of the sponsor
  8. Closure of the study as per the agreed timelines

Compliance Services

  1. Pre study Audits of CROs for conduct of bioequivalence / bioavailability studies / clinical facility audit / bioanalytical facility audit
  2. Facility audit for manufacturing and quality control laboratories

Diagnostic testing

Diagnostic testing plays a pivotal role in modern healthcare by aiding in the accurate identification, monitoring, and management of various medical conditions. Our diagnostic service is at the forefront of cutting-edge technology and expertise, dedicated to providing accurate and timely diagnoses for a wide range of medical conditions. Our team of highly trained and experienced professionals utilizes state-of-the-art equipment and techniques to deliver precise results. We are committed to offering comprehensive assessments, from routine screenings to complex diagnostic procedures, all with a focus on patient comfort and care. With a reputation for excellence in accuracy and efficiency, our diagnostic service plays a pivotal role in guiding healthcare decisions, ensuring early detection, and ultimately improving patient outcomes. Your health is our priority, and we take pride in delivering diagnostic excellence you can trust.

Microbiome Services

The human microbiome is a complex ecosystem of trillions of microorganisms, including bacteria, viruses, fungi, and other microbes, that reside in and on our bodies. Since our establishment in 2018, our mission has been to provide dependable and cost-effective laboratory research services. We are driven by a deep passion for research, with a focus on creating, advancing, and delivering groundbreaking solutions.