IVIVC  Evaluation
In today’s scenario, it is important for pharmaceutical companies who are mainly in generic business to have cost effective development of generic formulations especially solid dosages.

In generic product development major cost is of clinical studies i.e. more than 50% of total development cost. So, it is desirable to develop first time right formulation to pass bio-equivalence study and this can be achieved by evaluation of in-vitro study data and correlating it with available in-vivo data.

This evaluation of IVIVC becomes difficult for BCS class II, III & IV molecules and it is further complicated if the formulation to be developed is modified release or alternate route of administration are involved like vaginal route. So, here IVIVC evaluation service is provided to pharmaceutical companies by experts having wide experience in evaluating in-vitro in-vivo data and interpreting it to develop correlation.

IVIVC evaluation is done based on the in-vitro data generated by research team of the company and same is evaluated with reference to available clinical data on public domain or clinical data of pilot study is used to establish correlation. Based on inference of evaluation, sponsor/company is suggested i.e. whether to go ahead or modify the formulation.

Evaluation of IVIVC reduces the risk of bio-equivalence study substantially, therefore it is recommended.

We offer IVIVC evaluation for various dosage forms and specialized for Dry Powder Inhalers (DPI).

R&D Management

Every Pharmaceutical company invest a substantial amount of money in research & development activities, generally 3% to 8% of total sales turnover amount.

It is important that R&D activities should be managed in an efficient way, so that projects will be completed successfully in a defined timeframe with budgeted amount, but due to complexity of research work it is not easy. Generally it is observed that more than 60% projects in R&D dept. either goes beyond agreed timelines or completed with increased budgeted amount. This happens mainly due to non-professional managing of R&D activities.

In general the process of Project Management is not applicable for R&D due to complexities in research work. So, there is a need to manage Research Department with professional R&D Management to ensure timely completion of projects with efficient budget controls.

Novel Consultants team of experts has more than decade of experience in R&D Management and established R&D Management models in leading Indian & European Pharmaceutical companies. After implementation of R&D management model the productivity of R&D activities in these companies is improved substantially and got the major benefit in terms of timelines and reduced budgetary expenses.

Formulation Development

Novel Consultants guide R&D Scientists of pharmaceutical companies in developing various generic dosage forms for USA & European markets i.e. for filing ANDA & Dossiers. Novel Consultants help & guide in developing formulations for NDA filing.

Guidance available for following dosage forms :

1. Immediate Release
2. Modified Release (sustained release, time release, controlled release, delayed release etc.)
3. Orodispersible Tablets
4. Dispersible Tablets


5. Soft Gel Capsules


6. Oral Liquids
   • Solutions
   • Suspensions


7. Oral powders


8. Semi-solid Formulations
   • Creams
   • Ointments
   • Gels


9. Parentrals
   • Small volume parentrals
   • Large volume parentrals


10. Ophthalmics

Novel Consultants also guide in developing following NDDS products :

• Orodispersible films
• Depot Injections

Clinical Research

Novel Consultants offer following services for Clinical Research :

• Team of clinical experts assist in conducting Bioavailability & Bioequivalence studies in India & Europe for filing with EMA, USFDA, India (DCGI), MHRA, ANVISA Brazil, Mexico, Thailand, TGA, MCC, etc.


• Assist in conducting Clinical Studies Phase III especially for NDA & NDDS products in India & Europe.


• Clinical experts help in Clinical & Bio-analytical monitoring at clinical sites.

Other Services

Due-diligence for Pharmaceutical plants & CROs acquisition
API & Formulation manufacturers’ audit as vendor development
Guidance for implementing GMP, GLP & GCP
Help in resolving critical regulatory queries related to formulations