Empowering Pharma Innovation

Enhancing pharmaceutical companies’ efficiency towards achieving drug development goals.

Medication Pills and Capsules Isolated on Yellow background
About us

DK Pharma Solutions

A company established in 2024 with an aim to help pharmaceutical companies achieve their goal by means of  providing Augmented services in all the aspects related to Pharmaceutical drug Development.​

Mission:

To provide best possible quality solutions and consultation services to our clients within time and   budget.​

Vision
To become total & trusted service partner in Pharmaceutical drug development process.​

Our services

We Offer ​

Product Development through Dossier. (R&D Scale)​
Formulation Development (EB)​
Pharmaceutical, Biopharmaceutical & Bioequivalence Facilitation and consultant services​
Regulatory submission and other services.​
Product In/Out Licensing.​
Supplier/Buyer for APIs and excipients from different countries..​
Management of Accounts of different pharma companies​

We Facilitate

Helps in identifying CMOs, CROs, CDMOs
Single point contact in india in managing CMO,CRO &CDMOs on behalf of sponsors
Overseeing tech transfer activities between sites on behalf of sponsor​
Management of Accounts of different pharma companies over the Globe  from India in cost effective manner​

Facilitation in identification and Managing CMOs, CDMOs & CROs

We are operative on `15 CDMOs which can develop product for submission of various regulators
We are tied up with 10 CMOs which can manufacture for submission and commercialise the generic products to various regulatory regions​
We have reachability of 50+ CROs which can conduct preclinical, clinical trails & BA/BE studies​

Regulatory submission

Services provided by our Regulatory experts
ANDA Submission & review.​
ANDA deficiency review.​
ANDA suitability & Petition Filing.​
Annual report registration.​
CBE- 30 Application.​
C- GMP audit guidance & compliance for no 483 certification.​
Padder audit guidance compliance.​
Variation filings.​
Changing submission to  the agency.​

Account Management

Our expert Account team  has processing 100+ Indian and Abroad companies end to end support, following services we deal with​
Maintenance of books of accounts​
Personal and Business income tax preparations​
Project Reports​
GST​
Professional Tax​
E-TDS/TCS Returns filling and submissions​
Pan Cards​
Partner ship deed preparation and Filing​
PF, ESI & Other statutory work &​
Secretarial work ​
Selective-Focus Photo Of Pink Tablets
Photo Of Medicine On Person's Palm

Formulation Development

In association with our partner’s formulation development CRO (CMO), We offer the following formulation development services.​
Complete analytical development and validation as per ICH requirement.​
RLD evaluation : A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA).Nov 14, 2017 ​
Drug Excipients interaction study.​
Formulation development to match the dissolution property of RLD in OGD( Office of Generic Drugs) and multimedia dissolution.​
Accelerated stability in primary pack along with RLD​
 Scale up-identifying the critical process parameters and process optimization.​
Technology transfer​
 Bio-batch or exhibit batch manufacturing​

Product In/Out Licensing for Rest of world countries(ROW)​

Strong networking in ROW: Successful  management  In licensing and Out licensing of the dossier for various countries apart from USA​
Partnership with California based Pharma company: In-licensing of  Generic drugs for USA market.​
Close-up View Of Two Medicinal Tablets
Blue Medicine Pills on Heart Shape

Active Pharmaceutical Ingredient (API) Supplier sourcing & Country Device Master Files (DMF): 

       Master Plan
Strategic collaboration with many Indian companies who have a vast Experience of preparing EDMF ,US-DMF and DMF for semi regulated  Market.​
Act as a complete facilitating partner between our client Pharmaceutical companies and our trustworthy supplier companies.​
Identify the specific requirements of our client Pharmaceutical Companies for API, other Raw materials, intermediates and  Excipients.​
Find out the right sources from domestic market who can provide  all of the above mentioned efficiently  with proper quality and competitive cost with all the applicable Regulatory guidelines into consideration.​
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