what we help with.
Five areas of practice. Engagements are scoped to a specific problem and priced against it — there is no retainer you have to buy into before we look at your situation.
regulatory compliance
Indian pharmaceutical manufacturing is gated on paperwork that is unforgiving of guesswork — the wrong licence class, a product outside your approved list, or a label missing a mandatory element can stop a launch outright. This work maps what applies to your product and site, and gets the documentation into a state that survives scrutiny.
Typically for: Manufacturers preparing for licensing or inspection, and brand owners entering a new category.
Enquire about regulatory compliance →What this covers
- Manufacturing and loan-licence pathway assessment (Forms 25, 28 and state equivalents)
- Approved product list scope — what your site is actually cleared to make
- CDSCO mandatory labelling review against the applicable schedule
- Dossier and technical documentation structure
- Inspection readiness review and gap closure planning
manufacturing optimization
Most contract manufacturing sites do not have a capacity problem so much as a changeover and batch-sizing problem. This work looks at the line as it actually runs, quantifies where output is lost, and prioritises fixes by what they return rather than what is easiest to change.
Typically for: Sites under margin pressure, or scaling into higher volumes without adding capital equipment.
Enquire about manufacturing optimization →What this covers
- Line and batch-cycle analysis, including changeover and cleaning downtime
- Yield loss and rejection root-cause review
- Batch size and campaign planning against demand patterns
- Process validation strategy and technology transfer support
- Costing review — where unit economics genuinely move
quality assurance
A quality system is only as good as what happens on an ordinary Tuesday, not what is written in the SOP binder. This work reviews the systems you have, closes the gaps that matter, and makes deviation and CAPA handling something the floor can actually run.
Typically for: Sites building or rebuilding a quality system, or responding to audit observations.
Enquire about quality assurance →What this covers
- GMP gap assessment against Schedule M and WHO-GMP expectations
- SOP architecture — coverage, ownership and revision control
- Deviation, OOS and CAPA workflow design
- Change control and batch record review practice
- Internal audit programme and supplier qualification
product development
The gap between a formulation that works in a lab and one a factory can make reliably at scale is where most new products stall. This work covers that gap: formulation feasibility, stability planning, packaging decisions, and the documentation a product needs before it can be commercialised.
Typically for: Brand owners developing a first product, and manufacturers extending a portfolio.
Enquire about product development →What this covers
- Formulation feasibility and excipient selection review
- Stability study design and shelf-life planning
- Packaging and container-closure selection
- Scale-up planning from pilot to commercial batch
- Product documentation and specification setting
business strategy
Which products to make, whether to manufacture or outsource, and how to price against entrenched incumbents are decisions that compound. This work brings structure to them — market and portfolio analysis grounded in what your operation can realistically execute.
Typically for: Founders and leadership teams planning a launch, an expansion, or a sourcing change.
Enquire about business strategy →What this covers
- Portfolio and therapeutic-segment selection
- Make-versus-outsource analysis and manufacturer selection criteria
- Pricing and margin structure review
- Distribution and channel strategy
- Market entry planning for a new category or geography
describe the problem.
The fastest way to find out whether we are the right fit is to tell us what you are dealing with. If it is outside what we do, we will point you elsewhere.