Consulting and Registration Services

We offer Registration Services for CDSCO, ICMR, DSIR, BIS, AYUSH, FSSAI, NPPA, CIB & RC, NBAIM for Drugs & Cosmetics, Medical Device, In Vitro Diagnostics, Narcotics, Agrochemicals and Biopesticides.

We also offer wide range of services like Regulatory Support, Toxicology, Preclinical & Clinical DMPK, Biology – Efficacy Studies in Animal Models, Medicinal Chemistry, Synthetic Chemistry, Drug Discovery, Drug Development, Metabolite Studies, E-Fate Studies, Agrochemical Discovery & Development and many more.

We offer

Why We Offer Preclinical Research Services for OECD GLP and REACH Studies

With over 13 Years in this industry and our relations with various preclinical contract research organisations (CRO’s) enable you to choose the righteous offerings where services encompass a comprehensive range of range of in vivo non-GLP and GLP safety assessment solutions in both rodent and non-rodent species to thoroughly evaluate pharmaceuticals, biologics, animal health products, agrochemicals, and biocides.

How We Support

We encourage early interaction as a means to develop a regulatory strategy that is appropriate for the complexity of your project and provide guidance and support to your research teams developing and executing preclinical studies.

Solutions

Our solutions include Scientific, Regulatory and Strategic Guidance, Protocol Development, Project Management, IND-enabling and NDA-enabling toxicology, safety pharmacology, and laboratory services that meet global regulatory requirements, for both small and large molecules.

REACH Studies for INDUSTRIAL CHEMICALS

Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH Studies) is a regulatory requirement of European Chemical Agency (ECHA). We have experience and expertise in designing the REACH studies as per European Chemical Agency (ECHA) requirements and submission of the data in the International Uniform Chemical Information Database (IUCLID) format.

Annex VII (1 Tonne or More)

Bacterial Reverse Mutation Test (Ames Test) (OECD 471)
Acute Oral Toxicity Study in Rats (OECD 420/423/425)
Acute Dermal Irritation/Corrosion Study in Rabbits (OECD 404)
Acute Eye Irritation/Corrosion Study in Rabbits (OECD 405)
Skin Sensitization Study in Guinea Pigs (OECD 406) or
Local Lymph Node Assay (LLNA) in CBA/Ca mice (OECD 429)

Annex VIII (10 Tonnes or More)

Bacterial Reverse Mutation Test (Ames Test) (OECD 471)
In Vitro Mammalian Chromosomal Aberration Test (CHO cells) (OECD 473)
In Vitro Mammalian Cell Gene Mutation Test Using the HPRT and XPRT genes (OECD 476)
In Vitro Mammalian Cell Micronucleus Test (Human Peripheral Blood Lymphocytes-HPBL) (OECD 487)
Acute Oral Toxicity Study in Rats (OECD 420/423/425)
Acute Dermal Toxicity Study in Rats (OECD 402)
Acute Inhalation Study in Rats (OECD 403)
Acute Dermal Irritation/Corrosion Study in Rabbits (OECD 404)
Acute Eye Irritation/Corrosion Study in Rabbits (OECD 405)
Skin Sensitization Study in Guinea Pigs (OECD 406) or
Local Lymph Node Assay (LLNA) in CBA/Ca mice (OECD 429)
28 Day Repeated Dose (OECD 407)
Reproductive Toxicity (OECD 421)
Developmental Toxicity study (OECD 414)

Annex IX (100 Tonnes Or More)

Bacterial Reverse Mutation Test (Ames Test) (OECD 471)
In Vitro Mammalian Chromosomal Aberration Test (CHO cells) (OECD 473)
In Vitro Mammalian Cell Gene Mutation Test Using the Hprt and xprt genes (OECD 476)
In Vitro Mammalian Cell Micronucleus Test (Human Peripheral Blood Lymphocytes-HPBL) (OECD 487)
Mammalian Erythrocyte Micronucleus Test (OECD 474)
Mammalian Bone Marrow Chromosomal Aberration Test (OECD 475)
Acute Oral Toxicity Study in Rats (OECD 420/423/425)
Acute Dermal Toxicity Study in Rats (OECD 402)
Acute Inhalation Study in Rats (OECD 403)
Acute Dermal Irritation/Corrosion Study in Rabbits (OECD 404)
Acute Eye Irritation/Corrosion Study in Rabbits (OECD 405)
Skin Sensitization Study in Guinea Pigs (OECD 406)
Local Lymph Node Assay (LLNA) in CBA/Ca mice (OECD 429) or
90 Day Repeated Dose (OECD 408)
Reproductive Toxicity (OECD 421)
Developmental Toxicity Study-Rats (OECD 414)
Extended One-Generation Reproduction Toxicity Study in Rats (OECD 443)

Annex X (1000 Tonnes or More)

Bacterial Reverse Mutation Test (Ames Test) (OECD 471)
In Vitro Mammalian Chromosomal Aberration Test (CHO cells) (OECD 473)
In Vitro Mammalian Cell Gene Mutation Test Using the Hprt and xprt genes (OECD 476)
In Vitro Mammalian Cell Micronucleus Test (Human Peripheral Blood Lymphocytes-HPBL) (OECD 487)
Mammalian Erythrocyte Micronucleus Test (OECD 474)
Mammalian Bone Marrow Chromosomal Aberration Test (OECD 475)
Acute Oral Toxicity Study in Rats (OECD 420/423/425)
Acute Dermal Toxicity Study in Rats (OECD 402)
Acute Inhalation Study in Rats (OECD 403)
Acute Dermal Irritation/Corrosion Study in Rabbits (OECD 404)
Acute Eye Irritation/Corrosion Study in Rabbits (OECD 405)
Skin Sensitization Study in Guinea Pigs (OECD 406) or
Local Lymph Node Assay (LLNA) in CBA/Ca mice (OECD 429)
90 Day Repeated Dose (OECD 408)
Reproductive Toxicity (OECD 421)
Developmental Toxicity Study-Rats & Rabbits (OECD 414)
Extended One-Generation Reproduction Toxicity Study in Rats (OECD 443)
Chronic Toxicity (OECD 452)/ Carcinogenicity (Oncogenicity) (OECD 451)

GLP Studies for AGROCHEMICALS

Physical Chemical Property Testing
Residue, Environment Fate and Behavior Studies
5 Batch Analysis

Genetic Toxicology Studies

Bacterial Reverse Mutation Test (Ames Test) (OECD 471)
In Vitro Mammalian Chromosomal Aberration Test (CHO cells) (OECD 473)
In Vitro Mammalian Chromosomal Aberration Test (Human Peripheral Blood Lymphocytes-HPBL) (OECD 473)
In Vitro Mammalian Cell Gene Mutation Test Using the HPRT and XPRT genes (OECD 476)
In Vitro Mammalian Cell Micronucleus Test (Human Peripheral Blood Lymphocytes-HPBL) (OECD 487)
In Vitro Mammalian Cell Gene Mutation Test Using the Thymidine Kinase Gene (OECD 490)
Mammalian Erythrocyte Micronucleus Test (OECD 474)
Mammalian Bone Marrow Chromosomal Aberration Test (OECD 475)

In Vitro Studies

EpiSkin-In Vitro Skin Corrosion (OECD 431)
EpiSkin-In Vitro Skin Irritation (OECD 439)
In Vitro Eye Irritation [Bovine Corneal Opacity and Permeability (BCOP) Test] (OECD 437)
In Vitro Eye Irritation EpiOcular (OECD 492)
In Vitro Skin Sensitization [Dermal Peptide Reactivity Assay (DPRA)] (OECD 442C)
In Vitro Skin Sensitization- ARE-Nrf2 Luciferase Test Method [KeratinoSens] (OECD 442D)
In Vitro Skin Sensitization [Human Cell Line (U937-U-SENS) Activation Test (h-CLAT)] (OECD 442E)
In Vitro Skin Absorption: Franz Cell Diffusion Assay (OECD 428)
In vitro Cytotoxicity in Balb/c 3T3 LD50 (OECD 129)

Acute Studies

Acute Oral Toxicity Study in Rats (OECD 420/423/425)
Acute Dermal Toxicity Study in Rats (OECD 402)
Acute Inhalation Study in Rats (OECD 403)
Acute Dermal Irritation/Corrosion Study in Rabbits (OECD 404)
Acute Eye Irritation/Corrosion Study in Rabbits (OECD 405)
Skin Sensitization Study in Guinea Pigs (OECD 406)
Local Lymph Node Assay (LLNA) in CBA/Ca mice (OECD 429)

Repeated Dose

Dose range finding (7 to 14 day) toxicology studies in Mice/Rats
Dose range finding (7 to 14 day) toxicology studies in Beagle Dogs
28-day repeat dose toxicity studies in Mice/Rats
28-day repeat dose toxicity studies in Beagle Dogs
90-day repeat dose toxicity studies in Mice/Rats
90-day repeat dose toxicity studies in Beagle Dogs
21/28-day repeat dose dermal toxicity studies in Rats/Rabbits
90-day repeat dose dermal toxicity studies in Rats/Rabbits
28-day Inhalation toxicity studies in Rats
90-day Inhalation toxicity studies in Rats

Developmental & Reproductive Toxicology Studies

Prenatal Developmental Toxicity Study in Mice/rats/Rabbits (OECD 414)
One Generation Reproductive Toxicity Study in Mice/Rats (OECD 415)
Two Generation Reproductive Toxicity Study in Mice/Rats (OECD 416)
Reproduction/Developmental Toxicity Screening Test in Rats (OECD 421)
Combined Repeated Dose with Reproduction/Developmental Toxicity Screening Test in Rats (OECD 422)
Extended One-Generation Reproduction Toxicity Study in Rats (OECD 443)

Endocrine Disruption Studies

Uterotrophic Bioassay in Rats (OECD 440)
Hershberger Bioassay in Rats (OECD 441)

Neurotoxicity Studies

Delayed Neurotoxicity of Organophosphorus substances following acute exposure (OECD 418)
Delayed Neurotoxicity of Organophosphorus substances 28-day repeated dose study (OECD 419)
Neurotoxicity Study in Rats (OECD 424)
Developmental Neurotoxicity Study in Rats (OECD 426)

Chronic / Carcinogenicity / Oncogenicity Studies

Carcinogenicity study in Mice/Rats (OECD 451)
Chronic Toxicity studies in Mice/Rats (OECD 452)
Combined Chronic Toxicity/Carcinogenicity study in Mice/Rats (OECD 453)

Metabolism Studies-Using 14C labeled compounds

Toxicokinetics / Mass balance study in rats (OECD 417)
Skin absorption study in rats (OECD 427)
Metabolism in Livestock -Goat, Chicken and Swine (OECD 503)
Residues in Livestock -Goat, Chicken and Swine (OECD 505)

Ecotoxicology (Ecotox) studies

Acute toxicity test in fish
Acute toxicity test in daphnia
Acute toxicity test in alga
Acute toxicity test in earthworm
Acute toxicity test in honey bee (oral & contact)
Ready biodegradability study (carbon dioxide evolution test)
Acute Oral Toxicity Study in birds [Japanese Quails/Chicken/Pigeon] (OECD 223)
Avian Dietary Toxicity Study in Japanese Quails (OECD 205)
Reproductive Toxicity in Birds-Japanese Quails (OECD 206)

Cosmetics Product Testing and Studies

Cosmetics and consumer product testing is required to assess the toxicity and quality to responsibly, safely, and efficiently market this product without an unreasonable risk of injury to the consumer.

We offer following services:

In vitro Studies

Episkin-In Vitro Skin Corrosion (OECD 431)
Episkin-In Vitro Skin Irritation (OECD 439)
In Vitro Eye Irritation [Bovine Corneal Opacity and Permeability (BCOP) Test] (OECD 437)
In Vitro Eye Irritation EpiOcular (OECD 492)
In Vitro Skin Sensitization [Dermal Peptide Reactivity Assay (DPRA)](OECD 442C)
In Vitro Skin Sensitization- ARE-Nrf2 Luciferase Test Method [KeratinoSens] (OECD 442D)
In Vitro Skin Sensitization [Human Cell Line (U937-U-SENS) Activation Test (h-CLAT)] (OECD 442E)
In Vitro Skin Absorption: Franz Cell Diffusion Assay (OECD 428)
In Vitro cytotoxicity in Balb/c 3T3 LD50 (OECD 129)

Drug Discovery & Development

Conceptualise, and evaluate drug targets
Assay development
High-throughput screening (HTS)
Hit identification and hit-to-lead to lead-optimisation
PK-PD
Identification of Biomarker
Mechanism of action
Combination Studies
DMPK
Non-GLP and GLP Toxicology
IND filing

Preclinical Toxicology

Designing, Implementation and Management of Preclinical Testing Programs
Nonclinical overviews, interpretation, and positioning of data (toxicology study reports, literature, safety data)
Toxicological Risk Assessments for Impurities, Leachable & Extractable
Determination of Permitted Daily Exposure (PDE) and Occupational Exposure Limits
Environmental Risk Assessments
Gap analysis and independent data reviews
GLP study monitoring, including pre-placement and in-life study audits

Medicinal Chemistry

Rational Drug Design
IP Generation
Multi-Dimensional Optimisation (MDO)
X-ray crystallography

ADME

Absorption, Distribution, Metabolism, and Excretion related issues of the compounds translating preclinical information to clinical trials

Biology

Molecular Biology, Biochemistry, Cell Biology and in vivo biology
Evaluation of drug targets
Establishment of screening cascade
Mechanism of action
Identification of biomarkers
Combination studies
Efficient experimental design and data collection to qualify leads and clinical candidates

Synthetic Chemistry

Solutions for synthetic routes
Custom synthesis

Laboratory Infrastructure Setup

Integrated drug discovery and development centre including biology, chemistry, DMPK, Toxicology and translational labs
Animal house with AAALAC accreditations
OECD GLP Toxicology facility Setup as per OECD Guidelines
Biosafety Level 3 (BSL-3) Laboratory Setup
Design & Setup of Radiotracer Lab and Cyclotron Project

REVO - Comprehensive Toxicity Prediction Platform

REVO is a comprehensive toxicity prediction platform which provides multiple levels of toxicity alerts in compliance with the requirements of regulatory authorities for product approval.

It has robust and tested methodologies derived from the collective expertise of field toxicologists, scientific and data inputs from reputed research institutes. REVO is well accepted by the industry.

REVO provides alerts for genotoxicity along with probability values which indicate the significance of toxicophores.

The unique Three Pronged Approach of REVO combines reliable:

Decision tree methodology: It employs rule base in accordance with the results of Joint Research Centre’s European Chemicals Bureau`s hazard estimation based on the Benigni/Bossa rule base for genotoxic carcinogenicity and mutagenicity (Benigni et .al. JRC Scientific and Technical, 2008).
ANOVA methodology: It provides the significance of the toxicophores of carcinogenicity based on F-ratio and probability
SAR / QSAR models: The models provide qualitative prediction for mutagenicity and carcinogenicity along with confidence level of prediction based on applicability domain

Additionally REVO provides molecular fingerprint based similarity search in database of toxic compounds to increase confidence level of genotoxicity prediction.

REVO databases include:

Compounds having TD50 values reported for rats and mouse species from Handbook of Carcinogenic Potency and Genotoxicity Database of Gold and Zieger.
Ames dataset for Mutagenicity, CPDB dataset for mutagenicity and carcinogenicity and dataset for COMET assay.
REVO allows use of customers databases for its predictions where available.

REVO uses both Expert Rule based as well as Statistics based evaluation for genotoxic mutagenicity and carcinogenicity in accordance with ICH M7 guidelines. The QSTR models used in REVO are validated as per REACH guidelines as recommended by OECD Guidance.

Our reports are well accepted by the regulatory bodies (eg. EDQM, EMA, USFDA).

Agrochemicals Impurities

While generating the product specifications for global regulatory submissions, 5 Batch Analysis is essential for the registration of agrochemicals that is required to prove their chemical uniformity.

For Global Regulatory Submissions, Impurity Profiling is MUST and this is where we support you with our expertise, we perform impurity profiling of technical grade pesticides with complete profiling of the molecule including identifying and quantifying the impurities both process related and degradation by-products along with the quantification of active ingredient.

The impurities, being present usually in the range from a few percent to 0.1%, but in special cases at or below 0.01 mg/kg must be determined. The analysis and identification of the impurities may require the combined application of several instrumental analytical techniques such as GC-MS, LC-MS, GC-FTIR and high resolution NMR, In GC or HPLC quantitative analysis to separate the active ingredient from the impurities is of vital importance.

We analyse all types of molecules as per the international guidelines such as OECD, CIPAC, BIS, OPPTS, EPA, EU, ASTM, EEC, FDA, IP, USP, ICH, ABNT NBR, SANCO and WHO.

Regulatory Consultancy Services

DRUGS

Assists in Import Registration, New Drugs, Subsequent New Drugs,Clinical trials, Dual Use NOC, Test License, Registration & Renewals.

COSMETICS

Providing most efficient and comprehensive Regulatory solutions for Registrations of Cosmetics, Renewals, Amendments, Label Reviews

IN VITRO DIAGNOSTICS

Suggest Regulatory Direction in the all new MDR Rules. Guidance on Notified and Non Notified Devices, Registrations,Test Licenses and More

MEDICAL DEVICES

Provides Tailor Made Regulatory Solutions & Services in the midst of new MDR Rules & Regulations.

INDIAN AGENT REPRESENTATION

Offers Bespoke & On-demand Registration holding Services to Global Companies.

NARCOTICS

We provides Clear Regulatory pathway Under the Narcotic Drugs and Psychotropic Substances Act, 1985 Regulated by Central Bureau of Narcotics.

NIB NOIDA

Offers On-demand Testing Support Services at National Institute of Biologicals,Noida.

CDL KASAULI

Offers On-demand Testing Support Services at Central Drugs Laboratory, Kasauli.

VACCINES & BIOLOGICALS

We provide Consulting services for Registration and Import Licenses for Vaccines & Biologicals.

DSIR

Provides Consulting Services for Recognition under Department of Scientific & Industrial research to Help companies apply for Tax Benefits by having In house recognitions.

NPPA

Provides Consulting Services under drug prices control order 1995 – National Pharmaceutical Pricing Authority.

BUREAU OF INDIAN STANDARDS

We offers Product Certification Services for Products Covered under ISI & CRS Schemes under Bureau of Indian Standards.

VETERINARY

We offer end to end Service for Launching a New Veterinary product in Indifrom CDSCO

FSSAI(FOOD)

Offers Quick Submission & Approval under Wireless Planning & Coordination and ETA Approvals

AYUSH

We offer Guidance on approval for COPP(Certificate of Pharmaceutical Products) for AYUSH products

NBAIM CULTURE COLLECTION (NAIMCC)

Provides Consulting Services for General Deposit of Microorganisms, Safe Deposit of Microorganisms, Registration of Elite Microbes, Patent Deposits of Microorganisms, Supply of Microbial Cultures

CENTRAL INSECTICIDE BOARD(CIB)

Provides Consulting Services for Registration of various Pesticides, Insecticides, Fungicides, Herbicides, Household insecticides, Bio Pesticides, Bio-fertilizers and PGR U/s 9(3B), 9(3) & 9(4) of the Insecticides Act, 1968, Govt. of India., Registration under Section 9(4) Formulation, Registration under section 9(4) TIM, Export of Existing / New Technical/Formulations, Registration under Section 9(3)B, Enhancement of Product Shelf Life, Packing, RTT Permit, Endorsement for transfer of cir/Shifting the address/Company name change, Inclusion of products in schedule of Insecticides Act, 1968

AERB (Atomic Energy Regulatory Board) Approvals

Our expertise in the area of radioisotope is Radio labelling in general, Design of the radio tracer experiments, Radio iodination, Training in Radioactivity Handling, AERB (Atomic Energy Regulatory Board) Approval Process for use of radio tracer and for establishing Radiotracer Laboratory, Radio-pharmaceuticals,
Radioimmunoassay, Guidance and identifying radioisotope and labeled compound sourcing, Radio Safety Officer (RSO) Training, RSO Consultants

Need Advice?

Call Us for Registration Services for CDSCO, ICMR, DSIR, BIS, AYUSH, FSSAI, NPPA, CIB & RC, NBAIM for Drugs & Cosmetics, Medical Device, In Vitro Diagnostics, Narcotics, Agrochemicals and Bio-pesticides.

Our Services

Regulatory Support & Consultancy Services, GLP Studies for AGROCHEMICALS, REACH Studies for INDUSTRIAL CHEMICALS, Cosmetics Product Testing and Studies, Toxicology, Drug Discovery and Development, Laboratory Infrastructure Setup, REVO – Comprehensive Toxicity Prediction Platform, Agrochemicals Impurities, Carbon 14 Analysis, C-14 & Tritium for E-Fate Studies, Design & Setup of Radiotracer Lab and Cyclotron, ARC Catalogue Products, RadioLabeled Isotopes, Custom Synthesis of Radioactive Materials and UnLabeled Compounds for Agrochemicals & Pesticides, Fertilisers and Life Science Research.

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