Integra Softgel Consultants

About Us

Integra Pharma Consultants have expertise in soft gelatin capsule with more than 21 years rich Pharma experience, developed and delivered many high value and potential products.

We Provides technical services, product delivery, Excipient application, troubleshooting of capsules, training to development, production team and providing both technical and strategic inputs.

Having very good project management skills and have very good track record of handling of multiple partners of CRO/CMOs from US, Europe, Canada and India for delivering products.

We have good fortune of working for some of the top softgel manufacturers in the industry and we have co-developed and guided the best practices the softgel industry

Softgel Expert: Single point of contact (SPOC) for soft gels from development to commercial; Identifying and selection of softgel molecules for development and service support system for commercial products supply.

Proven track record of developing and filing more than 35 ANDAs (15 softgel ANDAs), 20+ softgels of Domestic/ROW; played stellar role in pharmaceutical product from early phase to commercialisation, including successful contribution to preparing regulatory dossier, CMC section.Provided significant contribution for markets of India and ROW

Hands on experience in building and functionalizing of soft gelatine and liquid filled hard gelatine capsules (installation of required machinery for improving commercial productivity).

Developed and commercialised deferent novel dosage forms including Lipid based drug delivery system (SMEDDS/SEDDS).

Efficient in responding for USFDA and Health Canada queries with stipulated time lines.

Good understanding and exposure at production level and trouble shooting of solid oral dosage forms

My vast experiences provides me the ability to improve any organisational need from basic training programs to development scientists, operators and other production personal for implementation of strategic growth initiatives.

I have a proven track record of substantial cost savings for companies with which I have worked.

Our Services

  • Development of soft gelatin and liquid filled hard gelatin capsule through QbD approach.

  • Trainings on Soft gel capsules, in process controls and product specification.

  • Troubles shooting in manufacturing of soft gelatin capsules and process improvements.

  • We help to improve productivity of soft gelatin capsules with cost savings.

  • Regulatory guidance for US product development and ANDA filing

  • Building facility of soft gelatine capsules (R&D model and Production line)

  • Third party independent investigations and gaps identification and remediation.

  • We guide to develop high potent oncology and teratogenic molecule. We execute and deliver the product for local market with short span of time

  • Building new platform technologies which helps value addition to the organisation.

  • Guidance and help in BE studies and Protocol review (Pilot and Pivotal studies).

  • Service support systems around existing products and process improvement.

  • Documentation part, Audit support and Independent investigation of OOS / OOT etc….

  • Optimisation of Formulation and manufacturing process with using DOE and QbD principles.

  • Detailed characterisation of contained closure system and developing equivalent devices.

  • Guidance to Pharma CROs, CMOs and Excipient manufacturers.

  • We have premier set of expertise, problem solving and innovation to meet customer and product needs.

  • We Provide solution for leakers and late leakers of soft gelatin capsules.

  • We assure you to manufacturing of solvent free soft gelatin capsules.

  • We have capable of developing nutraceutical products.

  • We help and take the responsibility in Capacity expansion and designing the production area

  1. Equipment selection

  2. Raw material selection

  3. Process flow optimisation

  4. Reduction in process variation

  • We help in selection of right die roll and designing he die rolls and wedge

  • We undertake servicing of regular servicing of encapsulation machine for smooth production.

  • Installation of new encapsulation machine (imported), inline with machine manufacturer; our personal have capable of IP/OP/QP for all softgel machinery and equipments.

  • We design and deliver change parts for all soft gel machines

Customer Reviews

Integra Pharma Consultants has been instrumental in the success of our soft gel capsule manufacturing. Their expertise and support have helped us deliver high-quality products to our customers.

We highly recommend Integra Pharma Consultants for their exceptional knowledge and experience in soft gel capsule manufacturing. They have been a valuable partner in our product development.

The team at Integra Pharma Consultants is highly professional and dedicated to delivering excellent results. We have been impressed with their technical expertise and strategic inputs.

Integra Pharma Consultants has provided invaluable support and guidance throughout our soft gel capsule manufacturing process. We are extremely satisfied with their services.

Contact Us

Email

Integra Softgel Consultants

Hyderabad, Telangana, India

+91 8008579307

+91 8790759988

mrniru@gmail.com

https://www.linkedin.com/in/niranjan-votari-347b0228