DEPARTMENT OF REGULATORY AFFAIRS

“State-of-the-art research facilities and a friendly learning ambience"

ABOUT THE DEPARTMENT

The Regulatory Affair department at R. C. Patel Institute of Pharmaceutical Education and Research is established in the year 2020-2021. The key task of the department is to train the postgraduate students in Regulatory Submissions, Annual Reports, Registrations and Listings, which will offer first-rate opportunities to students with high quality educational experience. M. Pharm in Regulatory Affairs recently started with the aim to provide a deeper understanding of pharmaceutical product regulatory submission process to USA, Europe, Japan, Australia and Canada etc. Department’s laboratory facilities include well equipped computer lab with Industry required, necessary softwares. The department endows wide opportunity to students and teaching staff to learn and analyse using software independently during academic curriculum.

The regulatory affairs (RA) department of a pharmaceutical company is responsible for obtaining approval for new pharmaceutical products and ensuring that approval is maintained for as long as the company wants to keep the product on the market. It is responsible for activities to assist in regulatory submission, annual reports, registrations and listings. Assure compliance with applicable medical device regulations per jurisdiction, guidance and standards.

Regulatory affairs officers act as a link between companies and regulatory authorities, ensuring that products are manufactured and distributed in compliance with appropriate legislation.

Regulatory affairs officers ensure that products such as cosmetics, pharmaceuticals, and veterinary medicines meet legislative requirements.

Key duties of the job include:

• Ensuring compliance with regulations set by the Regulatory Agencies
• Maintaining familiarity with company product ranges
• Planning, undertaking and overseeing product trials and regulatory inspections
• Keeping up to date with changes in regulatory legislation and guidelines
• Analysing complicated information, including trial data
• Offering advice about company policies, practices and systems
• Obtaining marketing permission
• Outlining requirements for labelling, storage and packaging
• Using a variety of specialist computer applications
• Liaising and negotiating with regulatory authorities
• Providing advice about regulations to manufacturers/scientists
• Writing comprehensible, user-friendly, clear product information leaflets and labels
• Ensuring that quality standards are met and submissions meet strict deadlines
• Preparing documentation.

RESEARCH & CONSULTANCY

The department undertakes research projects costing more than 1 Cr rupees from various government as well as private funding agencies including AICTE, UGC, DST, DBT, North Maharashtra University. These research grants helped the department in modernizing the labs with sophisticated instruments and working area as well. These grants also supported many research scholars and staff members for pursuing their PhDs. The sophisticated instruments procured through the research grants have helped them to do the research of high repute and the same has been published as articles in journals of high impact factor. About 200+ publications are there to the department credit. The department has organized three National Conferences and Faculty Development Program. The department has marked its importance in research activities and IPR by having 3 patents in the area of drug delivery. It has set up research collaborations within the university, with other universities and companies within India. Academic and research excellence is achieved by industrial training, interaction with expertise and organizing seminars and conferences to meet the current requirements of pharmaceutical Industries, academics and regulatory bodies. The department also has excellent placement record. A strong aluimni group comprising more than 300+ pass out students ready to do needful to place their juniors.

Completed Projects

1.Development and evaluation of Nasal Mucoadhesive Drug Delivery System

2.Studies of Gastro Retentive Dosage form for Eradication of H. Pylori

3.Formulation and Evaluation of Pulsatile Drug Delivery System

Ongoing Projects

1.Development of Novel Nanocarriers for nose to brain Drug delivery

2.Preparation and evaluation of rectal /vaginal drug delivery for prevention of HIV.

3.Development of novel lipid based nano-formulation of some Bioactive Polyphenols for the synergistic prophylactic treatment of cervical cancer.

4.Design and Evaluation of Extended Release Pellets for Chronotherapy of Rheumatoid Arthritis.

5.Noninvasive Nanoparticles Based Buccal Drug Delivery System for Oral Cancer Treatment.

6.Design ,Development and evaluation of Nanoparticulate Drug Delivery System for Poorly Water Soluble Drug.

7.Software Assited Design,Development Optimization and Characterization of lipidic Nanoparticle Drug Delivery System for enhancement of Solubility.

8.Formulation and evaluation of liquid crystals Based Drug Delivery System.

9.Design, Development and characterization of floating drug delivery system for biphasic release: Estimation of Shelf Life

10.Development of Methotrexate Nanostructured Lipid Carriers for Topical treatement of Psoriasis : Optimisation, evaluation and Clinical studies

11.Development of Polymeric Micelles for Brain-Tumor Targeting Through Nose.

12.Development Of Nanoemulsion Based Nose To Brain Delivery System Of Bioactive Phytophenols For Effective Treatment Of Brain Cancer

The staff members of the department are also having different roles such as reviewer of the journals and funding agencies, editorial board member of the journals, editor/ author for the textbooks, guest speaker, chairman/ evaluator/ convener/ co-ordinator in the seminars/ conferences. In the recent past, the department provided consultancy to neighbouring industry and academic institues.

Expertise Availabe

Development and evaluation of –

1.Multi-particulate Drug Delivery Systems

2.Sustained Release Dosage Forms

3.Immediate release dosage forms

4.Ocular Drug Delivery Systems

5.Nasal Drug Delivery Systems

6.Buccal Drug Delivery Systems

7.Transdermal Drug Delivery Systems (including iontophoresis and sonophoresis)

8.Implants

9.Semisolid dosage forms

10.Microspheres

11.Nanopharmaceuticals (nanoparticles, liposomes, solid lipid nanoparticles, dendrimers, etc).

12.Cosmeticeuticals and Neutraceuticals