Empowering Pharma Innovation
Enhancing pharmaceutical companies’ efficiency towards achieving drug development goals.
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
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.
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.