We have sister concern PERT PHARMA BPO, engaged in regulatory and other consultancy service for Pharma and Nutraceutical industry. 
Our offerings to the industry covers all the essentials, needed to complete regulatory processes and market requirements.
Particularly speaking for the need of Nutraceutical industry related to FSSAI we offers 

  • FSSAI License & Registration help

  • FSSAI Export / Import License

  • Central License of FSAAI

  • Query handling & reply

  • New product development

  • Scientific Backup, Seminars, Training, articles and literature based on strong scientific evidence

  • Website development & update

 

With our knowledge pool & expert team we can assure you timely delivery at affordable cost.

  • Regulatory service for Pharmaceutical Industry

  • Specialized services for industry Pre Clinical Services


Toxicological Studies
Acute toxicity, chronic toxicity, Neurotoxicity, Genotoxicity, Organ toxicity, Cardiotoxicity, Teratogenecity 

Histological Studies
Protocol designing, test selection, review of slides/results (Spine density study in brain TS makes histology department of PBRI as an outstanding laboratory) 

Biochemical and Haematological Studies 
IL estimation, CRP estimation, Blood insulin estimation, TNF-α estimation, Hemeoxygenase estimation, SOD, GSH, LPO, Catalase, Adiponectin estimation, Acetylcholinesterase estimation, LOX estimation, COX estimation, etc 

  • Receptor Binding Assay 

  • Pharmacokinetic Studies

  • Pharmacological Investigation


Study of drugs acting on: Cancer, CNS, CVS, Diabetes, Kidney stones, Immunity, Pathogens, Ulcer, Hepatic cells, Drug induced toxicity, Kidney Cells, oxidative stress etc. 

Molecular Biology 
In joint hands with biotechnology department, pharmacology department provides detail molecular level studies facility for assessing effect of drug at molecular level by using PCR, Blotting and ELISA 

 

Regulatory Affairs

  • Domestic Dossier formation & compilation.

  • Product approval on stability.

  • Product approval on Bio-equivalence/Clinical trial.

  • Any Justification.

  • Process Validation.

  • Analytical Method Validation.

  •  Country specific Dossier formation & compilation.

  •  CTD/ACTD for bulk drugs and dosage forms for export registration.

  •  Certificate of suitability.

  •  Bio-Availability /Bio-equivalence studies.

  •  Toxicological Studies.

 

Trouble Shooting Solutions for trouble shooting and consultation in -

  • Designing of protocols

  • Manufacturing of formulation

  • Pharmacodynamic studies

  • Toxicological studies

  • Pharmacokinetic studies

  • Preparation of documents for any compliance Medical Writing

  • ICH GCP compliant Clinical Study Reports (CSRs); Phases I to IV, including CSR Synopses for public disclosure

  • Study Protocols

  • Clinical and non clinical sections of the Common Technical Document (CTD) including summaries and overviews for EU or US Regulatory Authorities

  •  Investigator Brochures

  •  Patient safety narratives

  •  Patient information including Informed Consent and Patient Brochures

  •  Pharmacovigilance documents such as Periodic Safety Update Reports

  •  Standard Operating Procedures (SOPs) covering all aspects of drug development including the design, conduct and reporting of clinical trials and the outsourcing of Sponsor responsibilities to a Contract Research Organisation (CRO)

 

Scientific Communications

  • Conference materials (abstracts, poster presentations and slide sets)s)

  • Manuscripts

  • Editorial support

  • Journal/conference submission

  • Product website content (for both scientific and patient audiences)

  • Educational material for patients, healthcare professionals and pharmaceutical industry personnel

  • Medical marketing reviews and reports

  • Literature reviews

  • Publication planning

 

Marketing Support & Training

  • Marketing Communication, Literature, Visual Aid

  • Market Survey & Market Potential

  • New Product Development

  • Product Launch

  • Conference promotion

  • Product Training for Medico, Social and Online Sale.

  • Sales Training.

  • Field Staff Introduction Training.

  • Scientific training to Field Staff.

  • Job orientation Training.

  • Training to Back-up and Administrative Staff.

 

WHY PERTS SPORTS SCIENCES

  • Highly qualified & experienced Team of experts in the field

  • Result oriented products as per your expectations

  • Strong R & D

  • P2P Manufacturing with your Brand Name

  • Wide range of products

  • FSMS:ISO22000:2005 certified company

  • Quality Monitoring at each step of processing

  • Certified Quality - Batch to Batch certificate of analysis to ensure quality from NABL accredited independent lab.

  • Serve your customized requirements

  • FSSAI License as per norms

  • Timely delivery

  • Highest Business Ethics

  • Scientific Backup, Seminars, Training, articles and literatures as per your requirement

  • Knowledge pool to Answer to all your questions related to sports nutrition, Nutrition for special needs and Nutrition for health & Fitness or even to regulatory service

© 2018 by Perts Sports Science, JAIPUR, Rajasthan, India

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