PHARMACEUTICALS
The high risk of failure inherent in pharmaceutical and biopharmaceutical product development necessitates a strategic approach that prioritizes early identification and termination of non-prospective projects. This “fail fast, fail cheap” philosophy is increasingly pursued by companies through the outsourcing of preclinical development activities to cost-competitive locations in India. SCS Consulting Group leverages its scientific team’s extensive experience (over 100 years combined in GLP practices) and internationally recognized certifications (DABT) to provide a comprehensive suite of toxicology and pharmacology services. Our service portfolio is meticulously designed to align with OECD-approved test guidelines, ensuring the highest quality and regulatory compliance for our clients in the pharmaceutical and biotech industries.
YOUR TRUSTED PARTNER IN HBEL & RISK ASSESSMENT
Our Expertise, Your Advantage
We leverage our extensive experience working with large and medium-sized clients in core sectors, along with dedicated services for small and medium enterprises. Our team’s deep technical expertise encompasses a wide range of services, including:
| Service | Expertise | Target timeline* |
|---|---|---|
| HBEL | PDE OEL PDE+OEL | Product Specific Product Specific Product Specific |
| Risk Assessment | Cosmetics (CPSR) Pharmaceuticals Cohort of concerns (NDSRI and Nitrosamines) Impurities and packaging contaminants Novel proteins, Food additives, biologicals and naturals Medical Devices TRA Medical Device BER Extractables and Leachable | 4 weeks (10 ingredients)
2-3 week 2-3 week 3-4 week 2-3 week 1 month ≤ 2 month ≤ 2 month 2 week |
| Miscellaneous | In silico predication (US FDA approved software) MSDS Product MSDS Tox profiles SOP Writing Technical Training (45 min – 1 hr.) Pre-clinical CRO selection (work specific) Excipient, Starting Material, and Intermediate Qualification Cross-Contamination and Occupational Safety Assessments | 1 week 2 days 5 days 10 days 2 weeks – – – – |
GENERAL TOXICOLOGY
| Study Title | OECD TG# |
|---|---|
| Acute toxicity, single dose, rodents | 423 |
| Acute toxicity, single dose, rodents | 425 |
| Multiple dose 14 – 28 days, with recovery group | 407 |
| Multiple dose 90 days, with recovery group | 408 |
| Chronic toxicity in rodents, 6 months | 452 |
| Chronic toxicity in rodents, 12 months | 452 |
| Acute toxicity, dermal (full study) | 402 |
| Acute eye irritation in rabbit | 405 |
| Local irritancy in rabbit (skin) | 404 |
| Guinea pig maximization (Magnusson-Kligman) | 406 |
| Mouse ear swelling test | 406 |
| Phototoxicity test in mouse | 432 |
| Chronic toxicity 18 months in mouse | 451 |
| Chronic toxicity 2 years in rodents | 453 |
DEVELOPMENTAL & REPRODUCTIVE TOXICOLOGY
| Study Title | OECD TG# |
|---|---|
| Fertility, reproductive performance & early embryonic development (Seg. I) | 414 |
| Embryo fetal development (birth defects and embryo toxicity) teratology (Seg. II) | 415 |
| Pre and post natal Development (Seg. III) | 416 |
GENOTOXICITY
| Study Title | OECD TG# |
|---|---|
| Ames assay, in vitro | 471 |
| Chromosomal aberration, in vitro | 473 |
| Chromosomal aberration, in vitro | 473 |
| Chromosomal aberration, in vitro | 475 |
| Micronucleus in vivo | 474 |
IN SILICO GENOTOXICITY ASSESSMENT
In Silico Genotoxicity Assessment: Safeguarding Your Products with Cutting-Edge Technology Leverage our comprehensive analysis, adhering to ICH M7 guidelines, to predict potential genetic damage. This combines advanced computational methods (expert rule-based & statistical evaluations) with in-depth literature reviews for a robust genotoxicity assessment.
Accurate Nitrosamine Potency Prediction: Making Informed Decisions for Safer Products Our approach, aligned with CPCA guidelines, utilizes Read-Across analysis and Structure-Activity Relationship (SAR) principles for a comprehensive assessment of nitrosamine carcinogenicity potential.
Data-Driven Revolution for Drug Development: Accelerate Your Pipeline with Cutting-Edge Analytics Unlock the power of data analytics to transform your drug development process. We help you accelerate discovery and development, optimize clinical trials, boost sales and marketing effectiveness, and simplify compliance.
Specialized Safety Solutions for Agrochemicals: Ensuring the Safety of Your Products and Our Environment Our comprehensive genotoxicity assessment program, adhering to international safety guidelines, utilizes advanced methods (expert analysis, statistical modelling, in-depth literature reviews) to identify potential genotoxic mutagenicity and carcinogenicity in agrochemicals.
In today’s world of drug discovery and development, advanced technologies Aare revolutionising the process. We offer a suite of services that leverage cutting-edge science and data analytics to empower your journey.
What sets us apart
- Unmatched Predictive Power: We utilize extensive databases to predict structural alerts for genotoxicity, carcinogenicity, and mutagenicity.
- Data-Driven Insights: Statistical significance analysis of toxic fragments and ANOVA analysis with F-ratio and probability calculation provide a robust understanding.
- Advanced QSTR Models: We employ cutting-edge classification QSTR models for various toxicity endpoints.
- Comprehensive Reporting and Support: Receive a detailed analysis report with ongoing support to justify predictions even during regulatory inquiries.
Value Proposition
Forget the hidden costs! Unlike other platforms, our in-silico predictions come with expert interpretation and regulatory justification included. This ensures a smoother process and saves you time and money.
TOXICOLOGY SERVICES
Expert Toxicological Consulting and Regulatory Guidance
At SCS, we offer comprehensive toxicology services to support pharmaceutical, biotech, medical device, agrochemical, and chemical companies. Our team of highly experienced toxicologists collaborates with you to:
Toxicology Services
Expedite Research Goals: Leverage our expertise to efficiently conduct safety assessments and regulatory toxicology studies. Minimize Risk & Maximize Success: Gain critical insights into drug safety profiles for informed decision-making throughout development.
Our Services
Strategic Toxicological Consulting: Receive expert advice on navigating complex safety considerations.
Safety Assessment Studies: We design and manage safety pharmacology, reproductive toxicology, and other studies to meet regulatory requirements.
OECD GLP Expertise: Ensure the integrity of your studies with OECD GLP study monitoring, audits, and data review.
Regulatory Support:Seamlessly navigate regulatory processes with expert guidance on study protocols, reports, and dossier preparation (IBs, INDs, NDAs, CTAs, BLAs).
Risk Assessment & Safety Management: Identify hazards and implement strategies to minimize safety risks associated with drug candidates.
Regulatory Liaison: We represent you in interactions with regulatory authorities, ensuring smooth submissions and approvals.
Scientific Writing: Benefit from our team’s expertise in crafting high-quality regulatory documents.
Develop safe and effective drugs faster with SCS’s complete toxicology package. We cover general toxicology, repeated dose effects, genetic impact, developmental & reproductive risks, and environmental safety.
PHARMACOLOGY SERVICES
Fast-Track Drug Discovery with SCS Pharmacology Services
At SCS, we offer comprehensive consulting services to propel your drug development journey. Our team of highly skilled pharmacologists helps you:
Pharmacology Services
Reduce Time & Cost: Streamline your drug discovery process with efficient in vivo studies and robust disease models.
Validate New Targets: Ensure the success of your drug development strategy by rigorously testing and validating new therapeutic targets.
Our Expertise Spans Key Therapeutic Areas
Metabolic Disorders (diabetes, obesity)
Oncology (cancer)
Inflammation & Infectious Diseases
Respiratory Diseases
CNS Disorders
Unparalleled Experience in Disease Modeling
Our consultants possess in-depth knowledge and proven experience in developing and establishing animal disease models across various therapeutic areas.
We Offer a Broad Range of Services
In Vivo Study Design: We tailor in vivo studies to your specific drug candidate and research objectives.
Disease Model Development & Implementation: Establish reliable disease models to accurately assess drug efficacy.
In Vivo & Ex Vivo Study Management: Our team meticulously manages and monitors your studies for optimal results.
Non-invasive Preclinical Imaging: Leverage advanced imaging techniques to gain valuable insights into drug action.
Data Analysis & Reporting: We provide comprehensive analysis and reporting of your study data.
Safety Monitoring & Regulatory Compliance: Ensure the safety of your drug candidate and adhere to all regulatory standards.
Regulatory Liaison: We facilitate smooth communication with regulatory authorities for streamlined approvals.
Scientific Writing: Our team can assist with drafting study protocols, reports, and research papers.
Partner with SCS to accelerate your drug discovery program and bring innovative therapies to life.
REGULATORY AFFAIRS CONSULTING
Navigate Regulatory Hurdles with Confidence
Ensure a smooth path to market for your drugs, biologics, medical devices, healthcare, agrochemical products with our comprehensive regulatory consulting services.
Our team of experienced consultants offers a wide range of expertise to support pharmaceutical, biotech, agrochemical, and medical device companies throughout the development process.
Benefits of Partnering with SCS
Accelerate Development & Registration: Leverage our strategic guidance to expedite product approvals.
Reduce Risk & Ensure Compliance: Navigate complex regulations with confidence and minimize potential roadblocks.
Streamline Dossier Preparation & Submissions: Benefit from our team’s experience in crafting successful applications for various regulatory bodies (CIB&RC, DCGI, US FDA, US EPA, etc.).
Expert Scientific Writing: Gain access to our team’s skills in creating high-quality documents, reports, and dossiers.
Our Services
Regulatory Strategy Development: We collaborate with you to define a clear roadmap for regulatory success.
Due Diligence & Gap Analysis: Identify potential challenges and develop strategies to address them.
Scientific Advice & Expert Opinions: Obtain valuable insights from our team of scientific experts.
Special Protocol Assessments (SPAs):Seek regulatory guidance on innovative clinical trial designs.
Preclinical Toxicological Risk Assessment: Evaluate potential safety concerns and establish safe exposure levels (HBEL, OEL, PDE, ADI, ADE, etc.).
Regulatory Consultation Meetings: Prepare for and participate in productive discussions with regulatory agencies.
Product Classification & Medical Device Applications: Ensure your product is categorized correctly and navigate medical device approval processes.
Regulatory Liaison & Support: We facilitate smooth communication and interactions with regulatory authorities.
Comprehensive Dossier Preparation: Benefit from our expertise in creating high-quality dossiers tailored to specific regulatory requirements.
Flexible Collaboration
Our team adapts to your needs. We can act as your lead in regulatory matters or provide supplementary support and guidance to your existing staff.
Proven Track Record
We have a successful history of helping companies submitting applications and securing approvals from major regulatory agencies worldwide (US FDA, US EPA, EU, DCGI, CIB&RC, etc.).
Partner with SCS to navigate regulatory complexities and bring your innovative products to market faster.
Our Motto
Our ‘Client First’ motto drives us to prioritise regulatory challenges which allow both flexibility for the client and compliance to be a reference of excellence in the global supply of solutions for validation in order to enable regulatory compliance for companies of all sizes.
Vision
Following the best regulatory practices combining our expertise & experience with client’s insights
Mission
To deliver tangible and sustainable results to the clients by innovative proposals, digital transformation, information security and sustainability.
Medbotics LLP